Otsuka Pharmaceutical India Private Limited (OPI) is a Joint Venture between Otsuka Pharmaceutical Factory, Inc., Japan, and Mitsui & Co. Ltd., Japan, India, for Infusion Business in India and Emerging Markets. We primarily manufacture & market products across multiple markets and therapeutic segments. Being a leader in intravenous nutrition products, we are committed to being the best partner of patients and healthcare professionals in the field of clinical nutrition.
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Designation: Officer Quality Assurance
Location: Ahmedabad, Moraiya
Job Description:
- To take instructions from the Executive daily and report the activity done shift wise to Officer.
- 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.
- To perform routine IPQA monitoring like volume check, critical control step verification during the 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 Executive (Shift in charge).
- To get issued Soft copy from Corporate Quality Assurance (CQA) Department and prepare & review MBD and MPD.
- To convert approved MBD / MPD into of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) and then in the pdf format.
- To Submit a soft copy of MBD / MPD to CQA.
- 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.
- To raise requests for stability batch destruction after the expiry period is over.
- Receipt and handling of data loggers. Place data loggers in consignment at the time of shipment.
- To carry out reconciliation and physical verification of the returned goods.
- To verify headspace oxygen and dissolve oxygen during in-process monitoring.
- To verify logbooks, online documents, records, analysis reports, and other supporting documents related to products manufactured in the plant.
- To provide support to Executive and Sub-department Manager in the investigation, in case of any product complaints or deviation.
- To execute the Corrective and Preventive Action (CAPA) defined by the Quality Management System (QMS), as per the instruction of Executive.
- To verify secondary packing material at the time of issuance against Technical Package / Standard Material Requirement Form and approve the process step.
- To execute line clearance for routine packing activity, monitor each packing line at a regular time interval and sample collection. To report to Sub-department Manager and Department Head online in case of any abnormality is observed.
- To support trend analysis of the packing line monitoring and keep track of Out of Trend (OOT) results and report to Sub-department Manager.
- To execute the CAPA defined by QMS and as per instruction of Sub-department Manager.
- To give non-compliance reports to the respective departments in case of internal quality audits and report it to Sub-department Manager and Department Head
Qualification: B.Pharma/B.Sc, MS/M.Sc/M.Pharma
Experience: 2-6 Years
Salary: Negotiable
Contact Details:
Ms. Pooja Sharma
+91-9512047584
hrm.opmf-amd@otsukapharma.in
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