Qureos Mentor

Amneal Pharmaceuticals

<div>
 
 Job Description
 
 
 
 Responsible for document management like BMRs, BPRs, master SOPs etc..
 
 
 Responsible for preparation &amp; review of the master documents of production.
 
 
 Responsible to ensure UAF working in area.
 
 
 Responsible for the handling of change control, deviations, investigation &amp; CAPA, etc. Responsible for line clearance activity before commencing the operations.
 
 
 Responsible to check that all the records and logbooks related to manufacturing, Sterilization, washing and sterilization of equipment&rsquo;s.
 
 
 Responsible for preparation, review, revision, control, and implementation of standard operating procedures of sterile manufacturing department.
 
 
 Responsible to ensure cleaning and sanitization of General, Controlled &amp; Aseptic area.
 
 
 Inform immediately to department functional head for any observation/disturbance with respect to documents and machines found in area.
 
 
 Responsible for monitoring all the activities related to General, Control &amp; Aseptic area. Aseptic vial/bag filling , Responsible for vial washing , autoclave and terminal sterilization operation.
 
 
 
 Skills
 
 
 
 Complying with Good Manufacturing Practices (GMP) and regulatory standards (USFDA, MHRA, WHO, etc.).
 
 
 Completing Batch Packing Records (BPRs), logbooks, and deviation reports.
 
 
 Maintaining traceability and following SOPs strictly
 
 
 
 Qualifications
 
 
 
 B.Sc. /M.Sc. / B. Pharm / M.Pharm
</div>

Senior Executive-Manufacturing

<div>
 
 Job Description
 
 
 
 <ul>
 <li>
 Responsible to assist installation &amp; commissioning of plant machinery.
 </li>
 <li>
 Responsible for qualification &amp; documents related to qualification of plant machinery.
 </li>
 <li>
 Responsible for executing and installation of plant equipment&rsquo;s and monitor the site execution work in project.
 </li>
 <li>
 Responsible for maintenance and breakdown activity related to plant equipment / machineries.
 </li>
 <li>
 Responsible to procure &amp; maintain the critical spares inventory.
 </li>
 <li>
 Responsible to update and maintain all cGMP documents related to breakdown &amp; preventive maintenance of plant machinery as per SOP.
 </li>
 <li>
 Responsible to supervise the calibration activity and maintain the related documents.
 </li>
 <li>
 Responsible to generate tools and parts requirement for daily breakdown and preventive maintenance.
 </li>
 <li>
 Responsible to carry out all work as per cGMP and GEP.
 </li>
 <li>
 Responsible to update and maintain all cGMP documents related to breakdown and preventive maintenance as per SOP.
 </li>
 <li>
 Responsible for handling quality management documents i.e., Change control, Deviation, CAPA, Quality Risk Management etc..
 </li>
 <li>
 Responsible for co-ordination with vendors and purchase department
 </li>
 <li>
 Responsible for qualification &amp; documents related to qualification of plant machinery.
 </li>
 <li>
 To ensure that Preventive and Predictive Maintenance is carried out in co-ordination with the concerned departments as per planner.
 </li>
 <li>
 Preparation and review of QMS documentation.
 </li>
 <li>
 Skills
 
 
 </li>
 </ul>
 GDP
 
 
 GEP
 
 
 Maintenance skill for aseptic area &amp; equipment for Pharmaceuticals products
 
 
 Machine and instrument calibration
 
 
 Good communication
 
 
 Machine spares &amp; vendor development
 
 
 
 Qualifications
 
 
 
 Education: Diploma/ B.E.
 
 
 Total Experience - 3 - 7 Years of experience in engineering plant maintenance role for sterile manufacturing plant
</div>

Senior Executive - Project & Engineering (Plant Maintenance)

<div><ul><li>Responsible to assist installation &amp; commissioning of plant machinery.
</li><li>Responsible for qualification &amp; documents related to qualification of plant machinery.
</li><li>Responsible for executing and installation of plant equipment&rsquo;s and monitor the site execution work in project.
</li><li>Responsible for maintenance and breakdown activity related to plant equipment / machineries.
</li><li>Responsible to procure &amp; maintain the critical spares inventory.
</li><li>Responsible to update and maintain all cGMP documents related to breakdown &amp; preventive maintenance of plant machinery as per SOP.
</li><li>Responsible to supervise the calibration activity and maintain the related documents.
</li><li>Responsible to generate tools and parts requirement for daily breakdown and preventive maintenance.
</li><li>Responsible to carry out all work as per cGMP and GEP.
</li><li>Responsible to update and maintain all cGMP documents related to breakdown and preventive maintenance as per SOP.
</li><li>Responsible for handling quality management documents i.e., Change control, Deviation, CAPA, Quality Risk Management etc..
</li><li>Responsible for co-ordination with vendors and purchase department
</li><li>Responsible for qualification &amp; documents related to qualification of plant machinery.
</li><li>To ensure that Preventive and Predictive Maintenance is carried out in co-ordination with the concerned departments as per planner.
</li><li>Preparation and review of QMS documentation.
</li><li>Skills
</li> </ul>GDP
 GEP
 Maintenance skill for aseptic area &amp; equipment for Pharmaceuticals products
 Machine and instrument calibration
 Good communication
 Machine spares &amp; vendor development</div>
 <div>Education: Diploma/ B.E.
 
Total Experience - 3 - 7 Years of experience in engineering plant maintenance role for sterile manufacturing plant</div> <div></div>

<div>Job Description:
<ul><li>Prepare the supply plan based on a rolling forecast to ensure timely availability of products.
</li><li>Place purchase orders (PO) to Contract Manufacturing Organizations (CMOs) in line with defined lead times.
</li><li>Coordinate with CMOs to achieve seamless supply execution and meet delivery objectives.
</li><li>Collaborate with the Sales team to address shortfalls and manage excess inventory effectively.
</li><li>Manage and monitor work orders within the ERP system to ensure alignment with production and supply plans.
</li><li>Analyse key MIS (Management Information Systems) reports to support data-driven decision-making across the supply chain.
</li></ul>Required Skills:
<ul><li>Excel &amp; Data Analysis | Expert
</li><li>Communication Skills | Advanced</li></ul></div>
 <div><ul><li>Graduation in any Field
</li><li>MBA is Preferable</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>

Executive - Supply Chain Planning

<div>
 
 Essential Functions
 
 
 
 
 JOB DESCRIPTION
 
 
 
 <ul>
 <li>
 To ensure that validation system remain updated as per regulatory requirements and industry standards.
 </li>
 <li>
 Responsible for execution and review of Qualification / Re-Qualification and Validation activity ofEquipment / System / Facility and Plant utilities.
 </li>
 <li>
 Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respectiveQualification / Validation / Re-qualification activity for timely completion of activities.
 </li>
 <li>
 Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.
 </li>
 <li>
 Responsible to conduct sampling activity as per the protocols (Process Validation, Cleaning Validationetc..).
 </li>
 <li>
 Responsible for preparation, review and execution of risk assessment activity related to Equipment /Process / Facility / System.
 </li>
 <li>
 Responsible for preparation and follow up for collection of data related to Annual validation planner.
 </li>
 <li>
 Responsible for submission of qualification documents to RA as per requirement.
 </li>
 <li>
 Responsible for review of media fill BMR.
 </li>
 <li>
 Responsible for IPQA activities as per requirements.
 </li>
 <li>
 Responsible for review and approval of documents like Validation protocols, reports, QRM, SOPs etc..
 </li>
 <li>
 Responsible for the assessment &amp; review of Change Control, Deviation, CAPA, Investigation etc..
 </li>
 <li>
 Responsible for approval of URS, DQ and vendor/ suppliers documents related to qualification. Additional Responsibilities:
 </li>
 <li>
 Ensure readiness of validation documents and responses.
 </li>
 <li>
 Provide training to the validation team and relevant cross-functional personnel on new validation procedures, regulatory updates, and equipment/system validations to maintain compliance and consistency.
 </li>
 <li>
 Participate in Vendor Qualification and Technical Evaluation.
 </li>
 <li>
 Monitor and manage the lifecycle of validated systems, including periodic review, change management, and revalidation, to ensure sustained compliance and performance.
 </li>
 <li>
 To have cost saving, quality improvement, Time saving and innovative thinking approach.
 </li>
 <li>
 To have good written and verbal communication skills in English language.
 
 
 </li>
 </ul>
 
 Education
 
 
 
 
 QUALIFICATIONS
 
 
 
 <ul>
 <li>
 Bachelors Degree (BA/BS) B. Pharma - Required
 </li>
 <li>
 Master Degree (MS/MA) M. Sc - Preferred
 </li>
 <li>
 Master Degree (MS/MA) M. Pharma - Preferred
 
 
 </li>
 </ul>
 
 Experience
 
 
 
 <ul>
 <li>
 12 years or more in 12 - 15 Years
 
 
 </li>
 </ul>
 
 Skills
 
 
 
 <ul>
 <li>
 Regulatory Compliance &amp; Validation Guidelines (FDA, EMA, ICH, WHO) - Advanced
 </li>
 <li>
 Validation Master Plan (VMP) Development &amp; Execution - Advanced
 </li>
 <li>
 Process Validation (PV) for Oncological Injectables - Advanced
 </li>
 <li>
 Cleaning Validation (CIP/SIP) &amp; Residue Limit Justification - Advanced
 </li>
 <li>
 Aseptic Process Validation (Media Fill Studies) - Advanced
 </li>
 <li>
 Sterilization Validation - Advanced
 </li>
 <li>
 Equipment Qualification (DQ, IQ, OQ, PQ) - Mastery
 </li>
 <li>
 Environmental Monitoring &amp; HVAC Qualificationn - Advanced
 </li>
 <li>
 Deviation Handling, CAPA &amp; Change Control in Validation - Mastery
 </li>
 <li>
 Analytical Quality Assurance - Advanced
 </li>
 <li>
 Equipment &amp; Facility knowledge - Advanced
 </li>
 <li>
 Investigation - Mastery
 
 
 </li>
 </ul>
 
 Specialized Knowledge: Licenses:
 
 
 
 
 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>

Deputy General Manager, QA Validation

<div>JD:
<ul><li>Operate and monitor HVAC systems and Building Management System (BMS).
</li><li>Ensure optimal temperature, humidity, and air quality in controlled areas.
</li><li>Carry out routine checks and preventive maintenance of HVAC equipment.
</li><li>Log daily readings and report any deviations or abnormalities.
</li><li>Support breakdown maintenance and coordinate with service vendors.
</li><li>Maintain records of filter change, calibration, and servicing.
</li><li>Ensure adherence to safety and GMP standards in utility areas.
</li></ul>Skills :
<ul><li>Sound knowledge of HVAC systems, AHU, Chillers, Compressors, and BMS.
</li><li>Ability to monitor and control systems through SCADA or BMS interface.
</li><li>Troubleshooting skills for HVAC and automation panels.
</li><li>Understanding of cleanroom classifications and temperature/humidity controls.
</li><li>Basic electrical and mechanical maintenance know-how.
</li><li>Familiar with SOPs, logbooks, and documentation practices.
</li><li>Team coordination and communication skills</li></ul></div>
 <div>ITI/ Diploma in Instrumentation/ Refrigeration</div>

Assistant, HVAC & BMS

<div>Essential Functions
Assist in drafting, updating, and implementing compliance policies and procedures aligned with regulatory changes.
Ensure smooth functioning of the Compliance Program in India, in line with applicable local laws.
Develop and deliver compliance training, awareness campaigns, and communication collaterals for employees.
Review, monitor, and approve HCP/HCC/TPR-related business activities to ensure compliance with policies.
Implement and maintain internal controls to strengthen compliance governance.
Conduct quarterly compliance monitoring, identify risks, and recommend remediation measures.
Drive compliance culture initiatives through employee engagement programs.
Maintain compliance governance calendar, dashboards, and reports for senior management.
Support Third-Party Due Diligence processes and remediate identified risks.
Maintain accurate compliance records, reports, and documentation as per company policies.
Partner cross-functionally with Manufacturing, QA, QC, R&amp;D, Corporate Affairs, and other internal stakeholders to ensure compliance alignment.</div>
 <div>Education
Essential:
Degree/Certification in Compliance, Pharma Management, Business Administration, Finance, or related discipline.
Desirable:
Degree in Law (LLB/LLM).
Experience
Minimum 3&ndash;5 years of experience as a Compliance Officer in the pharmaceutical or healthcare industry.
Hands-on experience with compliance monitoring, audits, and regulatory requirements.
Exposure to international compliance standards will be an added advantage. 
Skills &amp; Competencies
Technical / Functional Knowledge:
India Compliance &amp; Regulations &ndash; Mastery
Compliance Monitoring &amp; Audit &ndash; Mastery
MS Office &ndash; Advanced
Core Competencies:
Stakeholder Management &ndash; Mastery
Communication Skills &ndash; Mastery
Organizational Capability &ndash; Mastery
Integrity &amp; Ethical Judgment &ndash; Mastery
Analytical &amp; Problem-Solving Skills &ndash; Advanced
Critical Thinking &ndash; Advanced
Behavioral Competencies:
Delivery Focus
Ownership &amp; Accountability
Cross-functional Collaboration
Cost &amp; Profitability Focus
Other Requirements
Willingness to travel as per business needs.
Strong interpersonal skills with the ability to influence and build compliance culture.</div> <div></div>

Assistant Manager, Compliance

Join Amneal Pharmaceuticals and explore 7   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

Senior Executive-Manufacturing

Senior Executive - Project & Engineering (Plant Maintenance)

Senior Executive - Project & Engineering (Plant Maintenance)

Executive - Supply Chain Planning

Deputy General Manager, QA Validation

Assistant, HVAC & BMS

Assistant Manager, Compliance