Associate Director Quality Control

Teva Pharmaceuticals; Goa; On-site; INR 1,800,000 - 2,500,000; Full time

Job summary

Teva Pharmaceuticals Goa site seeks a seasoned Quality Control Laboratory professional to lead and manage QC operations, ensuring compliance with Good Laboratory Practices and safety policies. You will oversee instrument qualification, calibration, deviations investigations, method transfers, and data integrity across the laboratory, coordinating with R&D and project managers.

The role covers budgeting, inventory, audits, and continuous improvement initiatives to optimize efficiency and ensure

Qualifications

• Bachelor or Master of Science / Pharmacy required.
• 15-20 years of experience in the pharmaceutical industry handling QC operations.

Responsibilities

• 1. Quality Control Laboratory operations in compliance with Good Laboratory Practices and Safety policies.
• 2. Selection, upgradation, procurement, installation and qualification of laboratory instruments and equipment.
• 3. Preparation and execution of cost improvement plans for the laboratory expenses.
• 4. Ensure calibration and preventive maintenance of laboratory instruments and equipment.
• 5. Monitor and ensure upkeep of laboratory standards.
• 6. Manage change controls, investigations of deviations/OOS/oot, and documentation.
• 7. Oversee analytical method validations and transfers.
• 8. Monitor Nitrosamine and Elemental Impurities projects and provide guidance.
• 9. Coordinate with R&D and other sites for method transfers and site transfer projects.
• 10. Ensure quality of raw materials, intermediates, packaging materials, and finished products.
• 11. Participate in global projects and audits.
• 12. Stability management and documentation.
• 13. Documentation review of specifications, test methods, and SOPs.
• 14. Budget, Capex, and inventory management for QC laboratory.
• 15. Audit readiness and regulatory/customer inspections.
• 16. Data integrity and secure GxP data handling.
• 17. Operational excellence and cost- reduction initiatives.
• 18. Any other responsibility assigned by the reporting authority.

Education

Bachelor or Master of Science / Pharmacy

Job description

Role & responsibilities

1. Quality Control Laboratory

1.1 Handling all the Quality Control Laboratory operations in compliance with Good Laboratory Practices and Safety policies.

1.2 Selection, upgradation, procurement, installation and qualification of laboratory instruments and equipment.

1.3 Preparing and monitoring of Capex and Revenue budget for laboratory.

1.4 Preparation and execution of cost improvement plans for the laboratory expenses.

1.5 To identify the needs and to provide resources, adequate facility required for effective and efficient functioning of the department for timely analysis of samples.

2. Quality Management

2.1. Oversees the implementation of Standard Operating Procedures relating to the laboratory activities and compliance with the requirements of Good Laboratory practices.

2.2. Upgradation of laboratory systems as per the regulatory requirements.

2.3. Oversees calibration and preventive maintenance of laboratory instruments and equipment as per schedule, in accordance with approved Standard Operating Procedures. To arrange vendor assistance for AMC and other Instrument/ equipment breakdown.

2.4. To ensure upkeep and maintenance of all laboratory standards as per written procedures and to arrange the Laboratory standards based on forecast and priorities.

2.5. Responsible for monitoring the activities pertaining to upkeep and maintenance of Narcotics and controlled substances.

2.6. Assessment of Change controls initiated by Quality Control laboratory, other department and other sites and to ensure implementation of the correct procedure.

2.7. Manages investigations of Deviations/ OOS/ OOT/ Aberrant results related to laboratory, ensures that the Quality Documents are reported, investigated and its effect on product is assessed and documented.

2.8. Oversees Analytical Method validations to new and existing test methods, in accordance with approved protocols and Standard Operating Procedures.

2.9. Responsible for monitoring the activity related to Nitrosamine projects and providing technical Support and guidance.

2.10. Responsible for monitoring the activity related to Elemental Impurities projects and providing technical Support and guidance.

2.11. Interaction with R & D, project managers and other locations to discuss the progress of analytical activities such as analytical method transfers and execution of site transfer projects.

2.12. Ensures timely completion of analytical method validations and method transfers for the site transfer projects.

2.13. Responsible for ensuring the quality of raw material and packaging materials, intermediate, bulk and finished products is as per approved testing procedure.

2.14. To Monitor and ensure timely completion of ANDA, DMF change, Alternate vendor development projects.

2.15. To Participates in the Global projects assigned by reporting authority.

3. Stability Study

3.1. To ensure identification, tracking and Co-ordination of all stability batches packed at Goa site and at other approved packing site.

3.2. Responsible for activities related to stability management.

3.3. To ensure planning, supervision and review activities of Commercial Stability Study Samples, Hold Time study Sample, Temperature Excursion, and Thermal Cycling.

4. Documentation

4.1. Responsible for review of Specifications, Test Methods, Analytical Worksheet, Analytical Method Transfer/Verification/validation Protocol and Reports and Standard Operating Procedure of the Quality Control department.

4.2. Ensures review and approval of departmental and site documents.

5. Budget and Inventory Management

5.1. Ensure timely submission and monitoring of QC laboratory Capex budget.

5.2. Initiation of Capital Expenditure Request as per agreed Quarter to match cash flow and procurement of budgeted items.

5.3. Ensure completion of Unbudgeted Capital Expenditure Request as per requirement.

5.4. Capex assets and inventory management in co-ordination with Finance department.

6. Inspections/Audits

6.1. Participates in the self-inspection program conducted by the Quality Assurance Department.

6.2. Ensures Audit readiness of Quality Control Laboratory and to face all regulatory and customer inspections and ensure compliance.

6.3. Active participation in regulatory Audits, customer audits and compliance.

7. Data Integrity

7.1. To ensure compliance to the requirements of policy and procedures on Data Integrity.

7.2. To ensure that the GxP data handling is secure and adopt measures to ensure data Integrity.

7.3. To make sure that the current systems and practices are challenged to guarantee that data integrity is maintained.

8. Operational Excellence

8.1. Preparation and execution of cost improvement plans in co-ordination with OpEx team to reduce laboratory expenses.

8.2. OpEx initiatives in the laboratory such as Implementation of 5S standards for laboratory consumables, chemicals and instrument spares for easy traceability and to reduce searching time, Process simplification and efficiency enhancement.

8.3. Identification and execution of efficiency enhancement projects

9. Any other responsibility assigned by the reporting authority.

Education /Qualification:

Bachelor or Master of Science / Pharmacy

Experience:

15 20 years of experience in the Pharmaceutical Industry handling QC operations.