Job Description
Roles and Responsibilities
1. Review of the quality management system like cleaning, sampling, analyzing and
documenting the process.
2. Review and approval of analytical report, calibration reports, qualification reports
3. Review of customer complaints, root cause analysis, CAPA and ensure the implementation.
4. Review of QC SOPs and updation of the same where ever required.
5. Review of qualification documents (Design, installation, operation and performance),
preventive maintenance documents, calibration documents and etc.
6. On the job training to the new chemist as per the training schedule
7. Participating in Internal audit and follow up to complete the audit observation.
8. Ensuring the analysis as per the specification.
9. Compliance to internal audits & external audits
10. Review of certified reference standards and working standards documents and ensuring the
validity.
11. Review of Laboratory investigation for OOS and ensuring the CAPA implementation.
12. Training and maintaining GXP practices in quality control area.
13. Review of Specification and related documents in periodic basis and updation of the same
where ever required.
14. Investigation of deviation and ensuring the proper CAPA implementation.
15. Ensuring the requirement of 21 CFR part 11 and implementation in the work area.
Desired Candidate Profile
* Candidate should have 10-15 years of experience in Pharma API.
* should have good interpersonal skills and good communication skills.
* Capable to handle Team.