Senior/Chief Manager - QA - API Plant

Opening for Senior/Chief Manager-QA (API Plant) for Navi Mumbai Location.

Job Title:Senior Manager/Chief Manager- QA

Location: API Plant, Navi Mumbai

Department:Quality Assurance

Team Size:4

Reports To:General Manager-QA/QC

Job Summary: Heading & handling all QA activities such as Change control,gap analysis OOS,Deviations & failure/Non-Conformance investigation at API Plant

Qualification

Essential:B.Sc, M.Sc Desirable:B.Sc, M.Sc

Work experience: Overall:13-15 Years Relevant to the Job:12-14 years (atleast 4-5 years experience of managing team)

Key Deliverables:

1)Carry out gap analysis against guideline for SOP on CAPA, OOS, and OOT and revise SOP if required to further enhance the system.

2)Train the people and implement the system at respective sites December 2014

3)Make a monthly plan for data review and complete the review as per plan, prepare laboratory incident report or OOS report as applicable

4)Do the gap analysis of the current systems with ICH Q7A, 21 CFR & other EU/US guideline to further enhance system. Prepare gap analysis report every month in QA

5)Carry out gap analysis against applicable regulatory guidelines and industry standards in all GMP areas (other than QA/QC) at respective plants. Review and approve gap analysis report every month.

6) Bridge the gap by revision of QMS documents, training and monitoring the system. Prepare reports every month.

7)All regulatory and customer audit to be cleared without critical observation by this way.

8)Initiate strategy for QMS automation.

9)Strengthening of Laboratory investigations and OOS investigations and closure of OOS within stipulated timeframe.

10)Review documents such as MPR,BPR, Analytical protocols,standard test procedures, specification as per pharmacopoeia or regulatory requirements.

11)Review completed batch - production and lab control records before release for distribution.

12)Review & approve finished product COA.

13)Plan & conduct internal audit.

14)Review annual product quality review

15)Prepare & review validation protocols and reports.

16)Handle change control & deviation activity

17)Review OOS, complaint, rejected & returned product report.

18)Review stability data to support retest or expiry date.

1) Performing cGMP audits & ensuring compliances

2) Handling regulatory & customer audits

3) Making sure OOS,OOT & deviations are performed

4) Approving changes that potentially affect Intermediate & Finished API quality

5) Reviewing & approving SOPS, specification,batch manufacturing records(BMR) & other master documents

6) Imparting trainings on cGMP& ensuring effective training programme is available for new & existing employees for all relevant departments

7) Qualifying vendors for raw materials & packing materials as per defined procedure

8) Handling complaints,returns& recalls. Making sure investigations are performed & CAPA implementation

9) Releasing & rejecting finshed APIs & intermediates

10) Performing quality risk management related to instruments, equipments, documents, process,etc

11) Reviewing completed batch production & analytical records release of finished API for distribution along with SAP controls

12) Making sure that effective systems are available for document control

13) Approving contract manufacturing including contract laboratories

14) Reviewing & approving validation & qualification documents

15) Making sure that effective systems are available for maintaining & calibration of critical equipments& instruments

16) Making sure that there is stability data to support retest or expiry period & storage conditions for finished products & intermediates

17) Reviewing & approving annual product quality reviews

18) Coordinating with Regulatory department & supporting Regulatory compliances

19) Reviewing & approving Technology Transfer documents