Claris Otsuka Private Ltd. (Claris Otsuka), Ahmedabad is a Joint Venture between Claris Lifesciences Ltd., India, Otsuka Pharmaceutical Factory, Inc., Japan, and Mitsui & Co. Ltd., Japan, for Claris’ Infusion Business in India and Emerging Markets. With the strength of more than 1000, the organizational culture fosters high level of camaraderie, trust and sharing amongst its members.
Job Title – IPQA Officer/Sr. Officer
Experience – 2 – 6 Years
Location – Ahmedabad
Major Roles & Responsibilities:
1. To ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards and all
2. To take instructions from shift in-charge daily and report the activity done shift wise to shift in-charge.
3. To verify raw material, primary packing material at the time of material issuance and material dispensing against Technical Package / Standard Material Requirement Form and approve the process step.
4. To perform routine IPQA monitoring like volume check, critical control step verification during manufacturing of the product, sampling and periodic verification activities and if any deviation / abnormal observation in terms of noncompliance to Good Manufacturing Practice (GMP) observed, bring to the notice of Shift in charge.
5. To verify sample / good destruction process and report any gap to Department Head and take corrective and preventive action in coordination with respective Department Head.
6. To raise request for stability batch destruction after expiry period is over.
7. To receive and handle data loggers and to place the data loggers in consignment at the time of shipment.
8. To carry out reconciliation and physical verification of the returned goods.
9. To verify headspace oxygen and dissolve oxygen during in process monitoring.
10. To verify logbooks, online documents, records, analysis report and other supporting documents related to products manufactured in the plant.
11. To provide support to Section Head and Sub-department Manager in investigation, in case of any product complaints or deviation.
12. To execute the Corrective and Preventive Action (CAPA) defined by Quality Management System (QMS), as per instruction of Section Head.
13. To give non-compliance reports to the respective departments in case of internal quality audits and report it to Section Head and Department Head.
Skills Required- Functional/Behavioral:
1. Aseptic Processing and Sterile Product Processing Technologies
2. Lateral coordination
3. Team working
4. Policy compliance
5. Task completion orientation
- UG: B.Pharma – Pharmacy