The Quality Assurance (QA) Department in the pharmaceutical industry plays a crucial role in ensuring that products meet regulatory standards and are safe, effective, and of high quality. Its primary responsibilities include:
1. Compliance with Regulatory Requirements:
- Ensuring adherence to Good Manufacturing Practices (GMP) as outlined by regulatory bodies like the FDA, EMA, and WHO.
- Keeping updated on changes in regulatory guidelines and implementing them.
2. Documentation Control:
- Managing standard operating procedures (SOPs), batch manufacturing records, validation protocols, and audit reports.
- Maintaining proper records to ensure traceability and compliance.
3. Product Quality Control:
- Conducting in-process and final product testing to ensure consistency and quality.
- Reviewing product batch records and ensuring that products meet required specifications before release.
4. Auditing and Inspections:
- Conducting internal audits to ensure compliance with GMP, quality standards, and regulatory requirements.
- Preparing for external audits by regulatory agencies and clients.
5. Validation and Qualification:
- Overseeing the validation of manufacturing processes, cleaning methods, equipment, and analytical methods.
- Ensuring the qualification of facilities, utilities, and systems.
6. Deviation and Non-conformance Management:
- Investigating deviations, non-conformances, and complaints to identify root causes and implement corrective and preventive actions (CAPA).
7. Supplier and Vendor Qualification:
- Ensuring that suppliers and raw materials used in the production process meet quality standards through audits and performance reviews.
8. Training:
- Providing continuous training to employees on GMP, SOPs, quality standards, and safety procedures.
9. Change Control:
- Evaluating and controlling changes in the production process, equipment, materials, or procedures to assess their impact on product quality.
10. Risk Management:
- Identifying potential risks in production, quality control, and supply chain processes and implementing strategies to mitigate these risks.
By ensuring that every aspect of the production process is controlled and compliant, the QA department plays a critical role in safeguarding product integrity, patient safety, and the company’s reputation.
VerGo Pharma Research Laboratories Pvt. Ltd, a CDMO based in Verna, Goa is currently hiring:
Department : Development QA
Experience : upto 3 years experience in DQA or Analytical Development. (Hands on exposure in Method Validation and QMS)
Please mail you updated resumes trupti.prabhudessai@vergolabs.com
