Senior Quality Assurance Manager

Key Duties & Responsibilities

1 Plan, allocate and conduct routine analyses of In-process materials, Raw materials, Packing material, finished goods and stability samples within given time schedule. Responsible for the overall operational and technical efforts of QC lab, by directing the day-to-day operations in addition to execution of lab testing as per GMP.

2 Verify all processes are conforming to established quality standards and required customer MOA.

3 Interpret test results, compare with established specifications, and control limits, and make

recommendations on the appropriateness of data for release.

4 Investigate customer complaints regarding quality issues and close with proper CAPA.

5 Communicate quality control information to all relevant organizational departments.

6 Monitor the performance of quality control systems to ensure effectiveness and efficiency.

7 Implement quality control training programs.

8 Experience reviewing and approving method transfer and method validation protocols and reports

9 Experience reviewing and approving RM, FG, PM specification and method of Analysis and Stability Protocols for final product.

10 Experience performing oversight and audits of laboratories.

11 To check timely Calibration of QC instruments, General Maintenance, AMC and update related history card.

12 Responsible for NABL accreditation certificate.

13 To ensure the quality of raw materials, packaging materials and finished products are compliant with the approved specifications

14 To ensures that the Monitoring of the calibration program of equipment is done.

15 To provide technical support while troubleshooting problems such as Instrument, software, data etc.

16 Responsible for resource requirement in quality control department including Man and Machine.

17 To respond to customer query, DMF query with documentation.

18 Maintain a safe and healthy work environment by following standards, procedures, and legal

regulations.

19 Responsible for new product method development.

Education: B.Sc. / M.Sc. in Chemistry or Ph. D

Experience: Min15 years in pharma quality control labs

Competencies & Skillsets

Functional / Technical Behavioral

1) Planning and Execution.

2) Quality management System (QMS)

3) Data Integrity.

4) External/Internal Audits.

5) Effective team management.

6) Analytical Method Validation.

7) Qualification of Instruments.

1) People Manager

2) Flexibility

3) Ownership

4) Conflict management

5) Interpersonal skill

Looking a candidate from Local Ahmedabad (Who is ok with the Sanand location) and who know the Gujarati language as well.

PLs share you CV on [HIDDEN TEXT]