Qureos Mentor

Amneal Pharmaceuticals

<div>
 
 Job Responsibility
 
 
 
 
 JOB DESCRIPTION
 
 
 
 <ul>
 <li>
 Supervision of manufacturing, processing, packaging and holding of drug product as per define and approved procedures for stability batches and commercial batches.
 </li>
 <li>
 Maintaining the area and equipment in orderly manner as per cGMP requirements in a good state of repair and sanitized condition.
 </li>
 <li>
 To perform online documentation with respect to departmental procedures as per good documentation.
 </li>
 <li>
 To impart training of operation and cleaning related SOP to all subordinates and operators.
 </li>
 <li>
 Co-ordination for IQ / OQ for any new equipments / system.
 </li>
 <li>
 To perform PQ for any new equipments / system.
 </li>
 <li>
 To follow all concern departmental SOPs for day to day operation and cleaning.
 </li>
 <li>
 To handle and manage material movement as per defined procedure and approved Batch Manufacturing Record / Batch Packing Record.
 </li>
 <li>
 Review, execution and implementation of Batch Manufacturing Records, Batch Packaging Records, Process Study Protocols, Process Study Reports and all relevant Documents.
 </li>
 <li>
 To follow all safety rules and departmental general instructions.
 </li>
 <li>
 To perform work other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 Position - Officer - Granulation
 
 
 Education - B Pharma
 
 
 Experience - 04 years
 
 
 
 About Us
 
 
 
 Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
 
 
 
 About The Team
 
 
 
 The
 
 Human Resources team
 
 partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
 
 
 
 Key Roles That The Human Resources Team Performs
 
 
 
 Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
 
 
 Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
 
 
 Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
 
 
 Consultancy Role: Provide expert advice to the organization and it&rsquo;s managers on any aspect of workforce management and employee relations and performance.
 
 
 Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.
</div>

Officer - Granulation

<div><ul><li>Part of Technology Transfer Team (Under R&amp;D vertical ) at Pipan location
</li><li>Responsible for Preparation of Master BMR, BPRs and document management.
</li><li>Responsible for coordination with various departments like Regulatory Affairs, Manufacturing, Warehouse, Quality Assurance, Quality Control, Engineering for execution of Scale-up and Exhibit batches.
</li><li>Responsible for reviewing GMP related documents.
</li><li>Responsible to select Equipment at Facility.
</li><li>To facilitate the Change Controls to be logged for various reasons. To initiate the Change Controls due to revision in BMR / BPRs and other PD related changes.
</li><li>To study critical parameters during scale up batches to optimize the CPPs and CQAs.
</li><li>To provide the input related to batch size, process feasibility &amp; process parameters to formulation scientist as per requirement.
</li><li>To monitor and ensure readiness for execution of scale-up / feasibility batches, Exhibit batches with respect to RM, PM &amp; Miscellaneous items.
</li><li>Responsible for reviewing GMP related documents as applicable.
</li><li>To get actively involve in Scale-up and Exhibit batches.
</li><li>Activities other than the defined in the Job responsibility are to be done, as per the requirement of HOD, by following HOD&rsquo;s instruction and guidance.</li></ul></div>
 <div>B. Pharmacy / M. Pharmacy</div>
 <div>Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.</div>

Senior Executive, R&D Technology Transfer | Injectable

<div>Job Responsibilities:
<div><ul><li>Lead and mentor the global case processing team, fostering a collaborative and high-performance culture.
</li></ul><ul><li>Oversee daily operations, ensuring timely and accurate processing of adverse event reports.
</li></ul><ul><li>Conduct regular performance evaluations and provide feedback to team members.
</li></ul><ul><li>Manage the intake and triage of adverse event reports, ensuring compliance with internal and external regulatory requirements.
</li></ul><ul><li>Evaluate adverse event reports for quality and completeness, making determinations on seriousness, causality, and expectedness.
</li></ul><ul><li>Collaborate with cross-functional teams to resolve complex cases and support risk assessment activities.
</li></ul><ul><li>Ensure adherence to pharmacovigilance regulations and guidelines, including ICH, FDA, and EMA standards.
</li></ul><ul><li>Develop and implement corrective and preventive action (CAPA) plans in response to audit findings, inspections and internal deviations.
</li></ul><ul><li>Lead internal and external audits, preparing teams for inspections and ensuring readiness.
</li></ul><ul><li>Identify opportunities for process optimization and implement best practices in case processing.
</li></ul><ul><li>Monitor key performance indicators (KPIs) and prepare reports for management on case processing metrics and compliance activities.
</li></ul><ul><li>Stay current with industry trends and regulatory changes, adjusting processes accordingly.
</li></ul><ul><li>Develop training materials and conduct training sessions for staff on pharmacovigilance procedures and regulatory compliance.
</li></ul><ul><li>Foster a culture of continuous learning and professional development within the team.
</li></ul><ul><li>Provides inputs into responses to Medical inquiries from regulatory authorities or health care professionals on safety issues coming from MIRF (Medical Information Request Form).
</li></ul><ul><li>Support the development and revision of Standard Operating Procedures (SOPs), work instructions, templates, and training guidance materials.
</li></ul><ul><li>Lead and facilitate comprehensive training for all ICSR Processing team and ensuring adherence to best practices and regulatory standards.
</li></ul><ul><li>Ad Hoc Activities: Provides comprehensive support for pharmacovigilance-related projects and activities, as delegated by the Department Head/ Designee, to ensure operational efficiency and compliance.
</li></ul></div>Required Skills:
<ul><li>Pharmacovigilance Regulations (ICH, FDA, EMA) &ndash; Advanced
</li><li>Individual Case Safety Report (ICSR) Processing &ndash; Advanced
</li><li>Medical Assessment &amp; Benefit&ndash;Risk Thinking &ndash; Intermediate
</li><li>Coding Standards (MedDRA, WHO Drug) &ndash; Advanced
</li><li>Safety Database Management (Argus, ArisG, Veeva Vault Safety) &ndash; Advanced
</li><li>Global Reporting Requirements &ndash; Advanced
</li><li>Data Integrity &amp; ALCOA+ Principles &ndash; Advanced
</li><li>SOPs/WIs/Templates Authoring &ndash; Advanced
</li><li>Quality Management &amp; CAPA (Root Cause Analysis, FMEA) &ndash; Advanced
</li><li>Audit &amp; Inspection Readiness &ndash; Expert
</li><li>Deviation Management &amp; QMS &ndash; Advanced
</li><li>Compliance Monitoring &amp; Controls &ndash; Advanced
</li><li>Risk Management (ICH Q9 principles) &ndash; Advanced
</li><li>Operational Excellence - Advanced
</li><li>Leadership and People Management - Advanced</li></ul></div>
 <div>M.B.B.S (Bachelor of medicine and Bachelor of Surgery) or Doctor of Pharmacy
Minimum of 8 years of experience in pharmacovigilance, with at least 5 years in a managerial role.</div>
 <div>Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.</div>

Manager, Medical Reviewer | Global Case Processing Operations

<div>
 
 Job Description
 
 
 
 
 Job Responsibilities:
 
 
 
 <ul>
 <li>
 Lead and mentor the global case processing team, fostering a collaborative and high-performance culture.
 </li>
 <li>
 Oversee daily operations, ensuring timely and accurate processing of adverse event reports.
 </li>
 <li>
 Conduct regular performance evaluations and provide feedback to team members.
 </li>
 <li>
 Manage the intake and triage of adverse event reports, ensuring compliance with internal and external regulatory requirements.
 </li>
 <li>
 Evaluate adverse event reports for quality and completeness, making determinations on seriousness, causality, and expectedness.
 </li>
 <li>
 Collaborate with cross-functional teams to resolve complex cases and support risk assessment activities.
 </li>
 <li>
 Ensure adherence to pharmacovigilance regulations and guidelines, including ICH, FDA, and EMA standards.
 </li>
 <li>
 Develop and implement corrective and preventive action (CAPA) plans in response to audit findings, inspections and internal deviations.
 </li>
 <li>
 Lead internal and external audits, preparing teams for inspections and ensuring readiness.
 </li>
 <li>
 Identify opportunities for process optimization and implement best practices in case processing.
 </li>
 <li>
 Monitor key performance indicators (KPIs) and prepare reports for management on case processing metrics and compliance activities.
 </li>
 <li>
 Stay current with industry trends and regulatory changes, adjusting processes accordingly.
 </li>
 <li>
 Develop training materials and conduct training sessions for staff on pharmacovigilance procedures and regulatory compliance.
 </li>
 <li>
 Foster a culture of continuous learning and professional development within the team.
 </li>
 <li>
 Provides inputs into responses to Medical inquiries from regulatory authorities or health care professionals on safety issues coming from MIRF (Medical Information Request Form).
 </li>
 <li>
 Support the development and revision of Standard Operating Procedures (SOPs), work instructions, templates, and training guidance materials.
 </li>
 <li>
 Lead and facilitate comprehensive training for all ICSR Processing team and ensuring adherence to best practices and regulatory standards.
 </li>
 <li>
 Ad Hoc Activities: Provides comprehensive support for pharmacovigilance-related projects and activities, as delegated by the Department Head/ Designee, to ensure operational efficiency and compliance.
 
 
 </li>
 </ul>
 
 Required Skills
 
 
 
 <ul>
 <li>
 Pharmacovigilance Regulations (ICH, FDA, EMA) &ndash; Advanced
 </li>
 <li>
 Individual Case Safety Report (ICSR) Processing &ndash; Advanced
 </li>
 <li>
 Medical Assessment &amp; Benefit&ndash;Risk Thinking &ndash; Intermediate
 </li>
 <li>
 Coding Standards (MedDRA, WHO Drug) &ndash; Advanced
 </li>
 <li>
 Safety Database Management (Argus, ArisG, Veeva Vault Safety) &ndash; Advanced
 </li>
 <li>
 Global Reporting Requirements &ndash; Advanced
 </li>
 <li>
 Data Integrity &amp; ALCOA+ Principles &ndash; Advanced
 </li>
 <li>
 SOPs/WIs/Templates Authoring &ndash; Advanced
 </li>
 <li>
 Quality Management &amp; CAPA (Root Cause Analysis, FMEA) &ndash; Advanced
 </li>
 <li>
 Audit &amp; Inspection Readiness &ndash; Expert
 </li>
 <li>
 Deviation Management &amp; QMS &ndash; Advanced
 </li>
 <li>
 Compliance Monitoring &amp; Controls &ndash; Advanced
 </li>
 <li>
 Risk Management (ICH Q9 principles) &ndash; Advanced
 </li>
 <li>
 Operational Excellence - Advanced
 </li>
 <li>
 Leadership and People Management - Advanced
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 M.B.B.S (Bachelor of medicine and Bachelor of Surgery)
 
 or
 
 Doctor of Pharmacy
 
 
 
 Minimum of 8 years of experience in pharmacovigilance, with at least 5 years in a managerial role.
 
 
 
 About Us
 
 
 
 Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
 
 
 
 About The Team
 
 
 
 The
 
 Human Resources team
 
 partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
 
 
 
 Key Roles That The Human Resources Team Performs
 
 
 
 Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
 
 
 Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
 
 
 Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
 
 
 Consultancy Role: Provide expert advice to the organization and it&rsquo;s managers on any aspect of workforce management and employee relations and performance.
 
 
 Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.
</div>

<div>
 
 Job Description
 
 
 
 <ul>
 <li>
 Site survey and plotting of layout as per drawings.
 </li>
 <li>
 Interpretation of plans and specifications.
 </li>
 <li>
 Monitoring architectural, structural and finishing work execution as per drawings
 </li>
 <li>
 Monitoring work progress, quality, and compliance with building codes and regulations.
 </li>
 <li>
 Prepare and track schedules, ensure timely completion of project.
 </li>
 <li>
 Contractor management, bill checking as per tender BOQ.
 </li>
 <li>
 Co-ordination with seniors, contractors, and other professionals to meet the project outcomes.
 </li>
 <li>
 Preparing and sending daily progress report.
 </li>
 <li>
 Work with cross functional teams for timely completion.
 </li>
 <li>
 Monitoring Quality of works as per IS
 </li>
 <li>
 Inspects materials and judge work quality for conformance with contract
 </li>
 <li>
 Testing on site of materials as per ITP and QAP.
 </li>
 <li>
 Knowledge of safety practices, permits and norms.
 </li>
 <li>
 Knowledge of AutoCAD, civil estimation, MS Project/Primavera, and QA/QC protocols.
 </li>
 <li>
 Knowledge of cleanroom panels, cGMP practices, different type of finishes in pharma industry.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 8-10yrs experience
 
 
 
 About Us
 
 
 
 Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
</div>

Assistant Manager, Civil Engineering

<div>
 
 Job Description
 
 
 
 Maintain and follow the procedure as per SOP in day to day activity of warehouse.
 
 
 Receipt of materials, Physical verification and Preparation of Good Receipt Note in ERP systems and mail to concern user and purchase department.
 
 
 Affix status label (Quarantine) on all received materials and movement as per status updating.
 
 
 To update the record as per cGMP (like cleaning, balance verification, temperature, humidity, dispensing log book etc..) for day to day activities.
 
 
 To coordinate with the production, QCC, QA and Maintenance department for smooth functioning of department relevant activity.
 
 
 Storage of materials as per their storage condition.
 
 
 To transfer the approved Raw materials and Packaging material from the Quarantine area to release area after receiving approved GRN from QC.
 
 
 To perform material retest date monitoring, transfer the material from approved area tender test area, give intimation QC and issuance for resampling.
 
 
 Issuance/ Dispensing of material like Raw/ Packaging /Misc. materials as per BMR/ BPR and Material Requisition slip.
 
 
 To deduct issued material from software and maintenance of stock record.
 
 
 Physical Stock verification as per schedule.
 
 
 Project work related warehouse execution.
 
 
 Review of QMS (quality management system) related document like CCF/Deviation/CAPA etc.
 
 
 Responsible for overall ERP function monitoring and report generation as per requirement. Ensure that all Finished Good Receipts (Transfer) from operation material management are done asper the norms and SOP to be followed by respective working staff for safe material handling, proper storage, temperature condition and documentation. equipment qualification activity.
 
 
 Executing and reviewing of MM department Monthly stock statement forwarding finance.
 
 
 Review of SOP for material management and other department, Raw Material / Packing Materials receipt, storage and issuance, Handling of Finished Goods receipt/issuance and dispatches, Handling of QMS activity, participation in scheduled RQ, Qualification of area and equipment
 
 
 
 Skills
 
 
 
 Accurate recording in stock registers, bin cards, and warehouse management systems (WMS).
 
 
 Completing material issuance records, receipt logs, and dispensing logs.
 
 
 Complying with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP).
 
 
 
 Qualifications
 
 
 
 Graduate /M.Sc. / B. Pharm / M. Pharm
</div>

Store & Warehouse - Senior Executive

<div><ul><li>Acting individually and in cross-functional teams along with the in-house counsel to develop and implement intellectual property strategies
</li><li>Conduct prior art searches, analyse the IP landscape to identify the white space, work closely with the R&amp;D teams to build robust patenting strategies to support the business.
</li><li>Draft, file, and prosecute patent applications worldwide both directly and through management of in-house or outside counsel.
</li><li>Challenge and defend patents in IPR, opposition, interference, and other post-grant proceedings.
</li><li>Provide legal advice under the direction of counsel to cross-functional R&amp;D and business teams on a variety of IP-related prosecution matters</li></ul></div>
 <div><ul><li>PhD in chemistry from reputed institute or Masters in Medicinal Chemistry along with minimum 2 years to experience as R&amp;D Scientist in Pharmaceutical/ life science company.
</li><li>7-10 years of experience in handling and managing patent portfolio related to New chemical entity and its formulation, at a law firm and/or life sciences company, including substantial U.S. patent prosecution
</li><li>Technical background relevant for pharmaceutical patent prosecution, such as:
<ul><li>Experience with small molecule, peptides and/or biological pharmaceutical discovery &amp; formulation development
</li></ul></li><li>Strong legal, analytical, communication, collaboration skills.
</li><li>Demonstrated ability to manage complex projects to meet deadlines.</li></ul></div>
 <div>Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.</div>

Senior Manager, Intellectual Property

Join Amneal Pharmaceuticals and explore 10   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Amneal Pharmaceuticals

ABOUT_COMPANY

Officer - Granulation

Senior Executive, R&D Technology Transfer | Injectable

Manager, Medical Reviewer | Global Case Processing Operations

Manager, Medical Reviewer | Global Case Processing Operations

Assistant Manager, Civil Engineering

Store & Warehouse - Senior Executive

Senior Manager, Intellectual Property