QA manager for Leading Pharma manufacturing company
1.Shall responsible to report Manager QA & RA, Director (Technical).
2.Shall responsible to review implementation & maintain of Quality Management system.
3.Checking & Maintaining of Master Documents related to QMS system.
4.Shall responsible to review filled Batch Production control record & analysis report for batch release.
5.Responsible for coordinate validation activity and prepare validation protocols.
6. Responsible for control and approve deviations whenever raised in the concerned department and record the deviations.
7.Review and approval of the standard operating procedure for another concern department.
8.Responsible to plan and carryout internal audits.
9.Responsible to Coordinate with Q.C./Production for handling and investigation of Market complaints.
10.Responsible for conducting on-going training programs for new recruits and retraining for existing employees of concern department on topic of GMP, WHO, ISO etc. whenever required or as per schedule
& Responsible for verifying effectiveness of training programs system.
11.To check and approve art works in coordination with Manager-QA & RA.
12.Verification and approval of the change control whenever the change in the document, facility, process and equipment.
13.Verification and approval of documents concern to production process & analysis.
14.Responsible for verifying the effectiveness of corrective action and preventive action system.
15.Responsible to review & maintain system represent in QA department SOPs like OOS, OOT, (document record, storage & retention),
Document control, APQR, Calibration, Trend data, etc.
16.Should have better co-ordination with QA, Production, Q.C. and Maintenance for implementation of cGMP.
1.In the absence of QA Manager, Manager - QA & RA will be responsible for job work related to QA Manager.
2.In absence of Manager– QA & RA, QA Manager will be responsible for job work related to Manager – QA & RA.
3.In absenteeism of QA Manager / RA & QA Manager, QA executive will be responsible for job work related to Manager – QA & RA.
Work Experience (In Year)
4 - 8
39/2, Bhilgaon, Kamptee Road, post- Khairi, District-Nagpur, Maharashtra- 441002