Opening For Officer- QA @ Otsuka
- Otsuka Pharmaceutical
- 2 - 6 years
- Ahmedabad
- 5 years ago
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Job Description
- To take instructions from Executive daily and report the activity done shiftwise 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 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 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 request for stability batch destruction after 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 report and other supporting documents related to products manufactured in the plant.
- To provide support to Executive and Sub-department Manager in investigation, in case of any product complaints or deviation.
- To execute the Corrective and Preventive Action (CAPA) defined by Quality Management System (QMS), as per 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 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 in 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.
Perks and Benefits
Best in IndustryJob Classification
Industry: Pharma, Biotech, Clinical ResearchFunctional Area: Production, Manufacturing, Maintenance,
Role Category: Production/Manufacturing/Maintenance
Role: Production/Manufacturing/Maintenance
Employement Type: Full time
Education
Under Graduation: B.Pharma in Pharmacy, B.Sc in Any SpecializationPost Graduation: M.Pharma in Pharmacy, MS/M.Sc(Science) in Any Specialization
Doctorate: Doctorate Not Required, Any Doctorate in Any Specialization
Contact Details:
Company: Otsuka PharmaceuticalAddress: Village - Vasana - Chacharwadi, AHMEDABAD, Gujarat - 382213,India
Location(s): Ahmedabad
Website: https://www.otsukapharma.in
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Keyskills: change control qa Validation Process Validation bpr bmr ipqa qms manufacturing deviation quality
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Otsuka Pharmaceutical
Otsuka Pharmaceutical India Private Limited (OPI) is a Joint Venture between Otsuka Pharmaceutical Factory, Inc., Japan and Mitsui & Co. Ltd., Japan for Infusion Business in India and Emerging Markets. We primarily manufacture & market products across multiple markets and therapeutic segment...
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