Quality Assurance Officer

About the Role

Responsible for overseeing and managing all aspects of quality control operations within the laboratory unit. The primary goal is to ensure that all laboratory activities, processes, and products meet the highest standards of quality, safety, and compliance with industry regulations. This role involves overseeing testing, inspection, auditing, and the implementation of corrective actions.

Key Responsibilities

Regulatory Affairs

• Ensure regulatory compliance with India CDSCO / Pharmacopeia, FDA regulations / ISO 9000, and others as applicable.
• Perform internal audits of the Quality System according to Indian and US FDA's Quality System Requirements, ISO 9001, or any other quality standard.
• Participate in external audits, including supplier audits, customer audits, and inspections by Indian and FDA's agencies and ISO Notifying Body.
• Conduct periodical evaluation of Suppliers and supplier development.
• Prepare documents and data for different Suppliers/contractors for audits.
• Submit reports from internal and external audits to appropriate personnel and initiate audit follow-up actions, including Corrective and Preventive Actions (CAPA).
• Provide support in the development of QMS procedures, instructions, and forms, ensuring continuous improvement of the quality management system.
• Participate in implementing CAPA actions.
• Manage and maintain all aspects of the Quality System, including Change Control, CAPA, Customer Complaints, and Compliance.
• File complaints to vendors; initiate corrective action requests; assess suppliers' CAPA reports; participate in suppliers' auditing and qualification process.

Quality/Regulatory General

• Perform the function of Official Correspondent in front of the FDA and other government authorities.
• Review and draft new business Quality Agreements.
• Supervise, coach, and develop all quality employees.
• Mentor, train, and recommend qualified employees for advancement.
• Perform the responsibilities of Quality Control Manager during their absence.
• Adhere to safety and security policies; participate in safety and security training and improvement projects.
• Report unsafe or unhealthy conditions and assist with emergency or investigative situations related to areas of responsibility.

Quality Assurance

• Maintain all controlled document files and test records in a timely and accurate manner.
• Maintain updated matrix of records; maintain backup copies of required records and archive.
• Participate in the qualification of packing processes and software validation as required.
• Coordinate associated training activities: develop training matrix for every position and annual/semi-annual training plans, initiate training requests, perform trainings, and maintain training records.
• Develop comprehensive Quality and Regulatory training programs for all employees.
• Create written procedures for identification, documentation, appropriate review and approval of RM (Raw Material), specifications, analytical methods, facilities, support systems, equipment, processing steps, labeling and packaging materials, and computer software.
• Establish written procedures assigning responsibility for sanitation and describing cleaning schedules, methods, equipment, and materials for cleaning buildings and facilities.
• Ensure written procedures for all activities carried out are established and followed.
• Ensure personnel practice good sanitation and health habits; implement appropriate measures to prevent cross-contamination.
• Ensure written procedures are established detailing the receipt, identification, storage, handling, sampling, testing, and approval or rejection of raw material containers and closures.
• Review completed laboratory control records of critical process steps before material release.
• Review and approve validation protocols and reports.
• Ensure data protection is established for all computerized systems.
• Check records of different departments as needed for audits.
• Validation of general, cleaning, analytical methods, in-process control, test procedures, computerized systems, and personnel responsible for design, review, approval, and documentation of each validation phase.
• Approve changes that potentially affect product quality and perform product quality reviews.
• Review all lots of raw materials that failed to meet established specifications.
• Review all critical deviations or non-conformances and related investigations.
• Review results of the stability monitoring program.
• Review all quality-related returns, complaints, and recalls.
• Review the adequacy of corrective actions.
• Evaluate and assess the results of the above reviews and decide whether corrective action or any revalidation shall be undertaken. Document reasons for corrective action and ensure agreed corrective actions are completed in a timely and effective manner.
• Ensure training is regularly conducted by qualified individuals, covering at a minimum, the employee's operations and functions.
• Ensure records of all trainings are maintained and periodically assessed.
• Investigate discrepancies established during reconciliation of labels issued, used, and returned.
• Ensure raw material containers and closures are handled and stored to prevent contamination.
• Verify each container or grouping of containers for raw material or each lot of raw material is appropriately identified as to its status (quarantined, approved, or rejected).
• Ensure each lot of raw material is withheld from use/export until sampled, tested, or examined, and released for use/export by QC.

Requirements & Tech Stack

• Quality Control
• Quality Assurance
• Regulatory Affairs
• ISO 9000
• FDA regulations
• CAPA
• QMS
• Validation
• Data Protection
• CDSCO
• Pharmacopeia

Qualifications

• Specific qualifications not detailed in the provided text.