Qureos Mentor

Amneal Pharmaceuticals

<div>
 
 Job Description
 
 
 
 
 Key Responsibilities:
 
 
 
 
 Compliance &amp; Documentation
 
 
 
 <ul>
 <li>
 Ensure all engineering activities are executed in compliance with cGMP, GEP, and site SOPs.
 </li>
 <li>
 Ensure compliance with Quality Management Systems (QMS) and applicable regulatory guidelines.
 </li>
 <li>
 Handle all quality documents related to engineering such as Change Controls, Deviations, CAPA, and Quality Risk Management.
 </li>
 <li>
 Review and update the respective planner and ensure compliance of activity on time.
 </li>
 <li>
 Prepare and revise SOPs for plant machinery, utilities, HVAC, and water systems.
 </li>
 <li>
 Support preventive maintenance execution as per the defined PM schedule and SOPs.
 </li>
 <li>
 Assist engineers in installation and commissioning of new equipment.
 </li>
 <li>
 Ensure effectiveness of training through review, feedback, and improvement initiatives.
 </li>
 <li>
 Draft and update Job Descriptions for department personnel based on roles and responsibilities.
 
 
 </li>
 </ul>
 
 Department Training Coordinator Responsibilities
 
 
 
 <ul>
 <li>
 Act as the Training Coordinator for the Maintenance Department.
 </li>
 <li>
 Update classroom/adhoc training records in training software.
 </li>
 <li>
 Generate re-training requirements for SOP changes or compliance gaps.
 </li>
 <li>
 Prepare, review, and revise training matrices as per SOP changes or department needs.
 </li>
 <li>
 Identify and update training needs (TNI) and ensure compliance with training requirements.
 </li>
 <li>
 Manage user creation/inactivation and credential sharing in AIMS software or equivalent systems.
 </li>
 <li>
 Ensure new joiners are trained according to function mapping and training plan.
 </li>
 <li>
 Upload training materials (new/revised SOP copies) and track completion.
 </li>
 <li>
 Attend scheduled trainings and ensure personal and departmental training compliance.
 
 
 </li>
 </ul>
 
 Layout Preparation And Drawing Management
 
 
 
 <ul>
 <li>
 Prepare and develop engineering layouts, floor plans, equipment layouts, and utility layouts for new and existing projects using AutoCAD and related software.
 </li>
 <li>
 Create detailed technical drawings based on specifications provided by the engineering and project teams.
 </li>
 <li>
 Collaborate with project engineers, production, and utility teams to gather requirements and translate them into accurate and efficient layouts.
 </li>
 <li>
 Maintain proper storage, version control, and backup of all drawings received from vendors and those prepared internally.
 </li>
 <li>
 Review and validate vendor-provided drawings for technical accuracy and compliance with project standards.
 </li>
 <li>
 Conduct site measurements to verify and update "as-built" layouts post-installation.
 </li>
 <li>
 Generate drawing revisions based on feedback and ensure internal approvals are obtained before final release.
 
 
 </li>
 </ul>
 
 Audit Readiness &amp; Support
 
 
 
 <ul>
 <li>
 Ensure all systems, documents, and areas are audit-ready at all times.
 </li>
 <li>
 Participate in regulatory, customer, and internal audits, and coordinate timely closure of audit observations.
 </li>
 <li>
 Maintain compliance trackers and generate regular reports for the HOD and QA.
 
 
 </li>
 </ul>
 
 Other Duties
 
 
 
 <ul>
 <li>
 Perform additional assignments or responsibilities as assigned by the Head of Department (HOD).
 </li>
 <li>
 Contribute to continuous improvement initiatives within the department related to Operation and documentation.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 Qualification: B.E (Mechanical / Electrical)
 
 
 Experience: 4-6 years
</div>

Sr. Executive - QMS P&E - INJ

<div>Description:
The Purchasing Coordinator will support the various departments with creating and maintaining purchase orders and manufacturing, repair, and operational supplies. This role will collaborate closely with engineers, project managers, and suppliers to source, negotiate, and monitor orders, ensuring adherence to industry regulations and the company's quality standards.
Schedule:
1st Shift -7am - 3:30pm Monday to Friday 
 
Essential Functions:
<ul><li>Coordinate procurement of materials, spare parts, equipment, and services and contracts in support of facility operations and projects. Issue purchase orders, monitor order status, and expedite deliveries to meet project schedules.
</li><li>Maintain accurate purchasing records and documentation in compliance with GMP and internal quality standards. Evaluate supplier performance and participate in vendor qualification and audits as needed. Maintain and finalize annual service contracts. Establish new vendors as needed, update vendor records, and ensure records and documentation comply with GMP, finance, and quality standards.
</li><li>Maintain vendor relationships, conduct market research for quality and pricing, and negotiate prices. Coordinate with parts department, accounts payable, and vendors regarding material rejections, return processes, credit notes, and replacements.
</li><li>Maintain employee lockers and uniforms in coordination with employees and vendors.
</li><li>Develop key relationships with business stakeholders and ensure that purchase requisitions follow Company policies. Coordinate with various teams (internal &amp; external) to resolve invoice discrepancies.
</li><li>Collaborate with parts administration and maintenance teams to maintain critical parts availability. Generate daily, weekly, and monthly reports on inventory levels, procurement activities, and Capital Expenditure/Operating Expenditure (OPEX/CAPEX) expenditures to support informed decision-making by management.
</li></ul>Additional Responsibilities:
<ul><li>Performs other functions as required or assigned.
</li><li>update vendor records via Coupa System in coordination with Accounts Payable and Procurement</li></ul></div>
 <div>Education:
<ul><li>Bachelors Degree (BA/BS) Engineering, Manufacturing or related field - Required
</li></ul>Experience:
<ul><li>2 years or more in Procurement
</li></ul>Skills:
<ul><li>Excellent interpersonal and organizational skills; - Intermediate
</li><li>Ability to work with all levels within the company - Intermediate
</li><li>Excellent verbal and written communication skills - Intermediate
</li><li>Ability to multi-task - Intermediate
</li></ul>Specialized Knowledge:
<ul><li>Procurement 2 Pay Process, Inventory Management, GMP
</li></ul>The hourly base salary for this position ranges from $23.00 to $27.00 per hour. Amneal ranges reflect the Company&rsquo;s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life&rsquo;s many other commitments and opportunities.</div>
 <div>Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.</div>

Purchasing Coordinator

<div>Description:
As a member of the Engineering department, the Associate Director is accountable for the management of maintenance programs, projects, and initiatives. The role serves as the primary interface with manufacturing leaders, represents Engineering interest, and through influence ensure projects and initiatives delivers key site outcomes. The position is responsible for improving asset reliability and manufacturing capacity by providing business process improvements to drive the efficiency and effectiveness. The scope includes technical support and work execution in the field on engineering resolution of manufacturing mechanical or automation problems, processes in compliance with GMP, safety, and environmental regulations. 
 
Essential Functions:
<ul><li>Responsible for ensuring proper functioning of machinery, equipment and utilities and overseeing the following programs: validation, calibration, PM, BM, Pest Control, Environmental control, parts procurement and management, permits maintenance, sanitization, engineering SOPs implementation and training. Monitors maintenance performance and standards, investigates unusual trends and recommends necessary adjustments.
</li><li>Responsible for overseeing the following programs: validation, calibration, PM, BM, Purified Water, Pest Control, Environmental control, parts procurement and management, permits maintenance, sanitization, engineering SOPs implementation and training.
</li><li>Supervises trains and evaluates staff directly and through subordinate supervisors/lead workers; establishes and enforces operating and safety standards and procedures for maintenance services and repair; gives direction, resolves problems, prepares work schedules and sets deadlines to ensure completion of services.
</li><li>Coordinates preparation of the division's budget; monitors budget expenditures; analyzes staffing and expenditures requests; reviews requests for additional services; prepares contract specifications and negotiates and administers service and construction agreements for maintenance and alteration services.
</li><li>Conducts periodic inspections of facilities to review work in progress. Performs inspections of mechanical items, buildings, and HVAC systems. Reviews and recommends acceptance for equipment and supplies related to Building Facilities.
</li><li>Conduct surveys to ensure compliance and recommend or take corrective action as required. Write comprehensive reports and memos. Prepares/updates/approves engineering standard operating procedures. Maintains project files, databases, spreadsheets, related documentation and Log Books.
</li></ul>Additional Responsibilities:
<ul><li>Travel to different facilities
</li><li>Others duties as assigned.
</li><li>Responds to calls during emergency situations related to safety, production break-down or facility issues.
</li><li>Plans and assigns activities with other divisions/departments in association with project construction and remodeling.</li></ul></div>
 <div>Education:
<ul><li>Bachelors Degree (BA/BS) Engineering/Manufacturing - Required
</li></ul>Experience:
<ul><li>8 years or more in Engineering/Manufacturing
</li></ul>Skills:
<ul><li>Team building, communication, writing, planning, leadership, supervising, decision-making, and goal-setting. - Advanced
</li></ul>Specialized Knowledge:
<ul><li>Excellent knowledge of FDA regulations in a pharmaceutical environment. Experience in equipment and facility validation occupational hazards and safety codes. Purified water analysis and treatment. MEP maintenance, repair, construction methods and requirements. Principles and practices of personnel management and supervision. Building codes and ordinances and Americans with Disabilities Act (ADA) requirements. OSHA standards. Excellent computer skills; MS Word and Excel are a must. AutoCAD is a plus.
</li></ul>The base salary for this position ranges from $125,000 to $163,000 per year. Amneal ranges reflect the Company&rsquo;s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life&rsquo;s many other commitments and opportunities.</div>
 <div>Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.</div>

Associate Director, Facilities Engineering

<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

<div>1. Identify vendors for Electrical, Mechanical Instrumentation with aid of consultant and conduct technical discussions with the tenders provided by consultant. Subsequently hold commercial negotiations with vendors and finalize one vendor accordingly.
2. Collaborates in the planning of new facilities, scrutiny of building layouts, electrical work, and Mechanical and equipment finalization.
3. Administer expenditure controls and estimates construction costs.
4. Prepare work orders and ensure completion of activity as per the requirements and specified timelines.
5. Appropriate installation of pipe work with identification and with proper documentation.
6. Documentation of all the area and equipment&rsquo;s at the site as per Validation master plan.
7. Part of team for validations &amp; revalidations of all area and equipment&rsquo;s avail at site.
8. Prepare the work progress reports and materials reconciliation reports.
9. Preventive &amp; breakdown maintenance of utilities like boilers chilling point, cooling towers, water treatment plant, vacuum systems, pumps and air handling units.
10. Direct installation and alterations of machinery, equipment or other features as per SOP and change control.
11. Ensure that the factory acceptance test of equipment&rsquo;s is done before receipt at site wherever applicable.
12. Ensure that the site acceptance test of equipment&rsquo;s is done after receipt at site wherever applicable.
13. Preparation monitoring the Preventive maintenance policy of plant Equipment and utility equipment.
14. Responsible for Process Mechanical, Water System &amp; HVAC in the view of Operation &amp; Maintenance.
15. To ensure the completion of the maintenance activities and project activities as per specified timelines.
16. To follow the Electrical Safety Precautions.</div>
 <div>Qualification - B. Tech. / B E (Mechanical / Electrical / Electronics)</div> <div></div>

Manager, Facilities Engineering

<div>Key Responsibilities:
Equipment Operation &amp; Maintenance:
<ul><li>Overseeing the operation, maintenance, and repair of Water systems, Which shall include Pretreatment, PW generation, storage and distribution, WFI storage &amp; distribution, PSG system etc
</li><li>Implementing and managing Operation, preventive maintenance schedules as per SOPs to ensure optimal performance and minimize downtime.
</li><li>Troubleshooting and resolving issues related to Water system performance and efficiency.
</li><li>Ensure proper upkeep of all equipment related to Water system.
</li><li>Maintain proper documentation and records for all maintenance activities in compliance with SOPs.
</li><li>Ensure
</li></ul>Compliance with cGMP, GEP &amp; Documentation:
<ul><li>Ensure all maintenance activities are performed in compliance with current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEP), and standard safety protocols.
</li><li>Ensure that all engineering documentation are implemented as per GDP SOPS.
</li><li>Ensure compliance to all scheduled activities and record it.
</li><li>Participate in internal and external audits and ensure timely closure of observations related to maintenance.
</li></ul>Safety &amp; Housekeeping:
<ul><li>Adhere strictly to site safety policies and use proper PPE during all maintenance activities.
</li><li>Identify and mitigate potential safety risks associated with Water system equipment and maintenance activities.
</li><li>Maintain a clean and organized work environment in maintenance areas and around equipment.
</li><li>Support safety audits, risk assessments, and EHS initiatives in the plant.
</li></ul>Project Management:
<ul><li>Leading and executing Water system-related projects, such as system upgrades, new project or capacity expansions, and energy optimization initiatives.
</li><li>Coordinating with other departments and stakeholders to ensure projects are completed on time and within budget.
</li><li>Managing contractors vendors and internal teams for seamless project execution.
</li><li>Monitor execution of maintenance-related work during project activities, ensuring adherence to quality, safety, and engineering standards.
</li></ul>Spare Parts &amp; Inventory Management:
<ul><li>Identify and maintain critical spare parts inventory for essential equipment.
</li><li>Raise indent for spares and consumables as required and maintain it.
</li><li>Optimize spare usage and control maintenance costs without compromising reliability</li></ul></div>
 <div>Qualification: B.E. Electrical / Mechanical
 
Experience: 5-6 years
Installation and commissioning of Water equipment, Preventive maintenance and Breakdown maintenance of Water, Shift handling, Spare management, Documentation work.</div> <div></div>

Executive/ Senior Executive - Water System & HVAC

Join Amneal Pharmaceuticals and explore 6   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.