Job Description :

Manager Quality Control

- Responsible to manage analysis of validation batches including exhibit and commercial.

- Responsible for coordination with AR&D for Method transfer activities of new analytical methods.

- Responsible for method transfer to other formulation sites of the organization

- Responsible for investigating OOS / aberrant results and timely closure in accordance with compliance procedures.

- Evaluating and actively involving in responding various queries of RA department for submission batches.

- Responsible for conducting hold time study of products & establishing hold time for in-process samples.

- Reviewing qualification (IQ,OQ,PQ) and calibration documents of analytical instruments.

- Ensuring the traceability and integrity of laboratory data.

- Handling a team of 35 members covering PD Lab, exhibit validation & commercial validation.

- Evaluation of reported laboratory deviations / incidences and providing departmental approval.

- Review of analytical reports and approval of COAs for batch release

- Reviewing process validation, cleaning validation, hold time study protocols & reports.

- Handled independently major regulatory audits such as USFDA, TGA, ANVISA, WHO-GMP, MHRA.

Salary:INR 10,00,000 - 15,00,000 P.A.

Industry:Pharma / Biotech / Clinical Research

Functional Area:Production, Manufacturing, Maintenance

Role Category:Production/Manufacturing/Maintenance

Role:Quality Assurance/Quality Control Manager

Employment Type: Permanent Job, Full Time

Keyskills

quality control management method transfer process validation time study cleaning validation QC Managers Quality control OSD Tablets Capsules formulation

Desired Candidate Profile

Candidates should be a Male persons.

Dealing Only into OSD.

Should be into formulations.

Should face the audits like USFDA,MHRA etc

Education-

UG: B.Sc - Any Specialization

PG:MS/M.Sc(Science) - Any Specialization

Doctorate:Doctorate Not Required

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