Senior Manager CQA (Goa)

15 - 20 Years
Goa

Job Description

Position : Senior Manager - CQA

Reporting to : HOD (CQA)

Qualification : M.Sc Chemistry

Experience : About 15 - 20 Years

Location : Goa

Specific Knowledge : relevant experience in finished formulation Quality Control/Corporate Quality control.

Sound knowledge of cGMP and the latest regulatory requirements.

Having hands on experience of QC department equipment functioning, software functioning and expertise in QC documentation and software review.

Responsibilities:

1. To review and approve Change controls, Deviations and other quality system investigations provided by other Unichem locations and sent to Corporate for approval.
2. To thoroughly review and approve Vendor qualification documents including vendor questionnaires and to interact with the related departments to ensure documentation is completed as per the requirements.
3. To execute internal audits at all Unichem manufacturing locations and Corporate departments as per the Annual planner .To ensure the implementation of corrective and preventive actions of observed non conformances
4. To prepare and issue CQA guidelines to all sites and to maintain all CQA documentation in line with Good documentation practices.
5. To review and approve the SOPs of Corporate departments and to provide recommendations for improvement.
6. To review and approve the process validations protocol and reports, stability protocols, MPRs of manufacturing location and Corporate departments and equipment qualification documents and provide recommendation for improvements.
7. Support the Unichem locations for regulatory compliance.
8. To ensure that the thorough investigation has been done for stability OOS,OOT results, Deviations and appropriate CAPA are taken as per the specified procedures.

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Employment Type:Permanent Job, Full Time

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:B.Sc - Any Specialization, Other Graduate

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

Company Profile

Unichem Laboratories Ltd

We are a leading pharmaceutical company with an increasing focus on innovative research and developed markets. To augment our efforts in achieving our expansion and business plan we invite young and energetic people to take up responsible positions in our organisation
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Recruiter Name:HR

Contact Company:Unichem Laboratories Ltd

Website:http://careers.unichemlabs.com