Executive - IPQA, Ahmedabad (CMO)

This Position is exclusively based at Ahmedabad, Gujrat location. Candidate from Ahmedabad or working in Ahmedabad can apply.

Roles and Responsibilities

1. To ensure the compliance of cGMP at CMO site followed.
2. Monitoring of the validation / commercial activities and ensure the samples are collected at various stages as per the sampling protocol/SOPs.
3. Review of Master Documents of BMR, BPR, Specification/STPs and Protocols etc.
4. Review the online BMR/BPR and respective logbooks during execution of the batches.
5. Involved for execution / review of the Process Validation Protocol (PVP)/ Process Validation Report (PVR), Hold Time Study (HTS) Protocol and Reports.
6. Well versed with line clearances activity for processing as well as packing areas.
7. Must have sound knowledge on In-Process checks for tablets & Capsules.
8. Review and participate in manufacturing investigation of various QMS (i.e. Market complaint, OOS/OOT, Deviation etc.) in compliance with the regulatory requirements.
9. Participate in regulatory audits and its compliance verification as we as participate in internal audit / external audits of manufacturing sites.
10. Maintaining and tracking various activities at CMOs sites regarding batch releases.
11. Review of the PQRs.
12. Ensure batch release activities and to support on document requirements for regulated markets like COCs, declaration and approval letter.

Desired Candidate Profile

• Candidate should be M. Pharm with IPQA activities
• Exposure in regulatory markets (European regulatory and USFDA, WHO etc.)
• Good communication - Gujrati, English & Hindi
• Should have long term goal with Althera.
• Prefer early joiner at Ahmedabad location.

Perks and Benefits

Best in the Industry