Quality Assurance Officer job at Abacus Parenteral Drugs Limited | Apply Now

Responsibilities:

• Schedule, prepare protocol/reports and conduct process and cleaning validation.

• Provide ongoing training, motivation, coaching, support and correction to employees to ensure that quality standards are met.

• Responsible for investigation of deviations, complaints and recalls in coordination with RA.

• Issue controlled documents e.g. specifications, BMRS, BPRs, preventive maintenance, facility layouts, SOPs, protocol etc.

• Collect and compile statistical quality data, keeping accurate record of the same (APQR)

• Monitor cleaning of warehouses, temperature mapping and recording.

• Support the quality assurance team leaders to ensure the development of fit for purpose QA policies and procedures and monitor implementation and effectiveness of the same.

• Document and report quality issues to management and other departments.

• Verify the received materials on receipt and ensure that it adheres to the accepted quality limits.

• Carry out online inspections of documents for compliance to data integrity.

• Be responsible for Retention, issuance and destruction of all records.

• To follow up on the approved reprocessing and reworks.

• To follow up on the Approved Change controls, CAPA, Risk

• To ensure that the required initial and continuing training of quality control personnel is carried out and adapted according to the need.

• Issuing controlled documents.

• Deviation reporting on non-conforming activities.

• Line clearance for all production activities.

• Approval/Rejection on receipt of Starting materials.