Officer - Quality Assurance (IPQA)

GUFIC BIOSCIENCES LIMITED; Navsari; On-site; INR 420,000 - 680,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED is seeking personnel with experience in Injectable manufacturing to join the production quality assurance chain. The role covers line clearance, in-process checks, sampling, online rejection, and batch document review.

You will maintain GMP documentation, prepare QA SOPs, and support regulatory inspection readiness. The candidate will also oversee acceptance checks, annual quality reviews, change control, and CAPA investigations while ensuring proper batch numbering and

Qualifications

• Experience in Injectable plant operations.
• Line clearance and in-process checks experience.
• Sampling of in-process, finished product, control, stability, and CV samples as per procedure.
• Online rejection activities and environment monitoring in manufacturing/packaging areas.
• Review of batch manufacturing/packaging records and QC data.
• Maintain online documentation during manufacturing and packaging.
• Prepare/review Quality Assurance SOPs.
• Support re-processing and re-packing activities.
• Perform Acceptance Quality Limit and Pre-Dispatch inspection of finished product.
• Prepare Annual Product Quality Review.
• Maintain GMP documentation and periodic log reviews.
• Issue Batch Manufacturing/Batch Packing Records and assign batch numbers as per SOP.
• Assist change control/deviation/non-conformance/incident and CAPA/OOS investigations.
• Assist Head of Department for regulatory inspection preparation.

Responsibilities

• Experience with Injectable plant operations and compliance.
• Conduct line clearance and in-process checks in production.
• Sample submission for in-process, finished product, and stability per SOP.
• Monitor environment and handle online rejection activities in manufacturing areas.
• Review batch manufacturing, batch packaging, and QC data.
• Ensure online documentation during manufacturing/packaging.
• Draft/review QA SOPs and ensure adherence.
• Handle re-processing and re-packing tasks when required.
• Carry out AQL and Pre-Dispatch inspection of finished goods.
• Contribute to Annual Product Quality Review preparation.
• Maintain GMP-compliant documentation and periodic log reviews.
• Coordinate batch manufacturing/packing records and assign batch numbers.
• Lead or support Change Control, Deviation, CAPA, OOS investigations.
• Assist Head of Department for regulatory inspection readiness.

Job description

Role & responsibilities

• Candidate should have experience of Injectable plant only.
• Responsible for line clearance and in process checks of Production.
• Responsible for Sampling of in-process, Finished Product, control samples, stability samples, and Process Validation samples as per procedure.
• To ensure online rejection activities and environment monitoring in manufacturing and packaging areas.
• To review of batch documents (Batch Manufacturing, Batch Packaging records, and Quality Control analysis data of the batch).
• To ensure online documentation during manufacturing and packaging area.
• To prepare and review of Quality Assurance Standard Operating Procedures.
• To ensure Re-processing and Re-packing activity.
• Responsible to perform Acceptance Quality Limit and Pre Dispatch Inspection of finished product.
• Responsible for preparation of Annual Product Quality Review.
• Responsible to maintain the document as per current Good Manufacturing Practices and conduct periodical log review.
• Responsible for issuance of Batch Manufacturing Record and Batch Packing Record to the production department as per the production planning and allocate batch number to the product as per SOP.
• Responsible for initiate and handling of Change Control/Deviation/Non-Conformance /Incident and Market Complaints Investigation / CAPA / OOS phase II investigation.
• To assist the Head of Department for preparation of regulatory inspection.