Lead Specialist (Supervisor) – Quality Control
1. Schedule QC team for daily QC testing activities by ensuring timely analysis, documentation, and review of RM/PM/FP/IPC/Stability and Process validation samples as per predefined standards.
2. Write and / or review controlled documentation related to laboratory operations or testing such as SOP's, analytical protocols, analysis reports, forms and validation documents.
3. Ensure compliance with FDA/USP/EP/ICH/ChP regulations and internal controlled procedures in the QC Laboratory.
4. Ensure readiness of QC Laboratory in internal / external audits.
5. Maintain data integrity in Quality Control activities and ensure appropriate traceability.
6.Initiate change control documents.
7. Participate in stability program, method validations, technical transfer, method transfer and validation / qualification activities at the site.
8. Participate in New Product Introduction activities.
9.Participate in laboratory investigations. Document laboratory investigation activities or review and approve laboratory investigation reports.
10. Participate in site corrective action / preventive action (CAPA) program. Ensure timely completion of all commitments made under QMS.
11. Lead and participate in key performance indicators for improving laboratory efficiency, monitoring equipment performance.
12. Escalate the quality events, trends as appropriate to QC Manager/Head.
13. Remain abreast of current regulatory, pharmacopeia and cGMP trends.
14. Lead the QC team, evaluate competencies, assign responsibilities, monitor performance, counsel and provide guidance. Plan & monitor the training and development requirements, motivate staff appropriately to build a committed, motivated & competent team.
15. Participate in personnel decisions (interviewing, hiring, performance appraisals, promotions, termination, staff development, improvement plans) regarding subordinate staff.
16. Maintains a safe laboratory environment by implementing recommendations made by EHS.
17. Support in budget preparation for QC Laboratory.
18. Any other activities as and when assigned by the Superior.
EDUCATION: Degree in science or related discipline (e.g. Chemistry, Chemical Engineering, Biomedical Engineering).
EXPERIENCE: Minimum 5 years of quality control experience in pharmaceutical manufacturing industry and minimum 1 year of supervisory experience in managing team.
1. Schedule QC team for daily QC testing activities by ensuring timely analysis, documentation, and review of RM/PM/FP/IPC/Stability and Process validation samples as per predefined standards.
2. Write and / or review controlled documentation related to laboratory operations or testing such as SOP's, analytical protocols, analysis reports, forms and validation documents.
3. Ensure compliance with FDA/USP/EP/ICH/ChP regulations and internal controlled procedures in the QC Laboratory.
4. Ensure readiness of QC Laboratory in internal / external audits.
5. Maintain data integrity in Quality Control activities and ensure appropriate traceability.
6.Initiate change control documents.
7. Participate in stability program, method validations, technical transfer, method transfer and validation / qualification activities at the site.
8. Participate in New Product Introduction activities.
9.Participate in laboratory investigations. Document laboratory investigation activities or review and approve laboratory investigation reports.
10. Participate in site corrective action / preventive action (CAPA) program. Ensure timely completion of all commitments made under QMS.
11. Lead and participate in key performance indicators for improving laboratory efficiency, monitoring equipment performance.
12. Escalate the quality events, trends as appropriate to QC Manager/Head.
13. Remain abreast of current regulatory, pharmacopeia and cGMP trends.
14. Lead the QC team, evaluate competencies, assign responsibilities, monitor performance, counsel and provide guidance. Plan & monitor the training and development requirements, motivate staff appropriately to build a committed, motivated & competent team.
15. Participate in personnel decisions (interviewing, hiring, performance appraisals, promotions, termination, staff development, improvement plans) regarding subordinate staff.
16. Maintains a safe laboratory environment by implementing recommendations made by EHS.
17. Support in budget preparation for QC Laboratory.
18. Any other activities as and when assigned by the Superior.
EDUCATION: Degree in science or related discipline (e.g. Chemistry, Chemical Engineering, Biomedical Engineering).
EXPERIENCE: Minimum 5 years of quality control experience in pharmaceutical manufacturing industry and minimum 1 year of supervisory experience in managing team.