08 Sep
|
HCP Wellness Private
|
Bavla
08 Sep
HCP Wellness Private
Bavla
Job Title: QA Officer
Location: Factory Location
Department: Quality Assurance
Reports To: Quality Assurance Manager
Job Summary: The QA Officer ensures that all products, processes, and systems comply with quality standards and regulatory requirements. They play a critical role in maintaining GMP practices, performing audits, and ensuring consistent quality in all production activities.
Key Responsibilities:
1. Documentation and Record-Keeping: o Prepare, review, and approve Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and Batch Packaging Records (BPRs). o Ensure proper documentation in compliance with regulatory guidelines and Valuable Documentation Practices (GDP).
2. Compliance Monitoring: o Oversee adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other regulatory standards. o Conduct regular inspections of manufacturing and packaging areas for compliance.
3. Audits and Inspections: o Participate in internal and external audits, including regulatory inspections.
o Prepare audit reports and follow up on corrective and preventive actions (CAPAs).
4. Change Control and Deviations: o Manage and review change control processes to ensure compliance. o Investigate deviations, non-conformities, and out-of-specification (OOS) results, and implement CAPAs.
5. Training and Development: o Train employees on quality assurance policies, GMP, and SOPs. o Ensure that all staff are up-to-date with training requirements.
6. Quality Systems Management: o Handle quality incidents, product complaints, and recalls in coordination with the QA Manager. o Review and approve validations, qualifications, and equipment calibration reports.
7. Batch Release: o Perform final review of batch records to ensure compliance before product release. o Liaise with regulatory teams to ensure timely product release approvals. 8. Continuous Improvement: o Identify opportunities for process improvement and contribute to quality initiatives.
📌 QA Officer (Bavla)
🏢 HCP Wellness Private
📍 Bavla