Quality Assurance Manager

Job description

Role & responsibilities

1 Responsible for follow the Heath, Safety and environment norm as per company policy and

procedures.

2 Ensure quality standards for all products and manufacturing activities.

3 To organize, educate for and execute activity as per the norms of Quality Assurance objective.

4 Responsible for authorization of site master file.

5 Responsible for authorization of Quality Manual.

6 Responsible for authorization of validation master plan.

7 Approving changes that potentially impact intermediate or API quality and responsible for final

authorization of change control.

8 Making sure that critical deviations are investigated and resolved and responsible for final

authorization of deviation.

9 Responsible for authorization of process validation protocol and report.

10 Responsible for executing cleaning validation as per protocol and authorizing cleaning validation

protocol and report.

11 Approving qualification protocol and report.

12 To review Out of specification / Out of trend cases.

13 To handle the product recall system.

14 To review annual product review of the entire product.

15 To handle the product recall system.

16 To review annual product review of the entire product.

17 To investigate and resolve customers complaints.

18 Coordinate customer and regulatory audits.

19 Provide compliance to customer complaints by coordination with marketing department.

20 Compliance report of various audits by outside agencies and customer.

21 Training to Personnel.

22 Releasing or rejecting APIs and Intermediates. Releasing or rejecting intermediates for use outside

the control of manufacturing company.

23 Establishing the system to release or reject raw material, intermediate, packing and labeling

materials.

24 Approval of completed batch production record and laboratory control records.

25 Approving specification and standard operating procedure.

26 Making sure that the internal audit is performed as per SOP

27 Review and approve validation protocols and reports in consultation with user department.

28 Making sure that effective system is used for maintaining and calibrating critical equipment.

29 Vendor audit.

30 Implementation of stability studies program of finished products and intermediate to support retest

or expiry dates and storage condition.

31 To ensure all equipment require for Quality Control testing are calibrated and maintained in good

condition as per SOP.

32 Establishing the system to execute analytical method validation as per the protocol.

33 Ensure that the work force is highly motivated and aligned to the Company objectives.

34 Ensure that adequate quality manpower in line with the demands of the department.

35 Ensure clear role clarity for everyone in the department.

36 Ensure training and development of people ensuring career growth.

37 Co-ordinate with HR for recruitment and training.

38 Performance management through setting goals and timely evaluation.

Preferred candidate profile

Full time M.SC postgraduate candidates preferred

Role: QA / QC Manager

Industry Type: Pharmaceutical & Life Sciences

Department: Quality Assurance

Employment Type: Full Time, Permanent

Role Category: Production & Manufacturing

Education

PG: MS/M.Sc(Science) in Chemistry

Key Skills

Skills highlighted with are preferred keyskills

API

Quality Assurance