Executive - IPQA, Ahmedabad (CMO)

About the company

Althera Laboratories is a pharmaceutical development and commercialization organization with operations across the US, Europe, and India. Its headquarters are in Ireland. The company’s purpose is to improve patients’ lives by introducing innovative and complex products through in-house development and partnerships with other innovators. Its approach is built around patient-focused values that are central to long-term success.

Role overview

This role is based only in Ahmedabad, Gujarat. Applications are expected from candidates who are already in Ahmedabad or currently working there.

Key responsibilities

• Ensure cGMP compliance is consistently maintained at the CMO site.
• Monitor validation and commercial activities, and confirm that samples are drawn at each stage in line with the sampling protocol and SOPs.
• Examine master records such as BMR, BPR, specifications, STPs, and related protocols.
• Check online BMR/BPR records and the associated logbooks while batches are being executed.
• Take part in the preparation and review of Process Validation Protocols and Reports, as well as Hold Time Study Protocols and Reports.
• Handle line clearance activities for both manufacturing and packing areas.
• Apply strong working knowledge of in-process checks for tablets and capsules.
• Review and support manufacturing investigations tied to quality management system events such as market complaints, OOS/OOT, and deviations, ensuring regulatory alignment.
• Participate in regulatory inspections and verify compliance, while also contributing to internal and external audits at manufacturing locations.
• Track and coordinate multiple CMO-side activities related to batch release.
• Review Product Quality Reviews (PQRs).
• Support batch release processes and documentation for regulated markets, including COCs, declarations, and approval letters.

Candidate profile

• M.Pharm qualification is required, preferably with prior exposure to IPQA work.
• Experience with regulated markets such as Europe, USFDA, and WHO is preferred.
• Strong communication ability in Gujarati, English, and Hindi is needed.
• The company is looking for someone who intends to stay long term.
• Early joiners based in Ahmedabad are preferred.

Perks and benefits

Compensation is described as best in the industry.

Additional information

This opportunity is specifically tied to the Ahmedabad, Gujarat location. Candidates from Ahmedabad or those currently employed there are eligible to apply.