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Quality Assurance Specialist
2 months ago
Piramal Pharma Solutions is seeking a highly skilled Quality Assurance Technician to join our team. As a Quality Assurance Technician, you will play a critical role in ensuring the quality and compliance of our products.
Key Responsibilities:- Quality Review and Compliance: Assist the QA officer in reviewing procedures, batch paperwork, and manufacturing and analytical documentation to ensure compliance with regulatory requirements.
- QA Representative: Serve as the QA representative for new campaigns, including process instruction sheets, change control, deviation, validation, customer audits, raw material and final product disposition.
- CAPA and Investigation: Participate in quality-related investigations, assist in the development and approval of effective CAPA to resolve production, audit, and customer issues.
- Validation and Audits: Participate in validation activities, including approval of protocols and reports for analytical methods, manufacturing processes, analytical/production/packaging equipment, and cleaning procedures.
- Supplier and Internal Audits: Participate in audits of suppliers, production, and support functions as required.
- Regulatory Compliance: Be involved in the preparation for MHRA/FDA and other regulatory body audits, highlighting potential issues to the QA manager.
- New Product Introduction: Act as the QA representative for the introduction of new products, ensuring that all cGMP documents are appropriate and all cGMP requirements are satisfied.
- Education: Bachelor's degree in a relevant field (e.g., life sciences, chemistry, or a related field).
- Experience: 1-2 years of experience in a quality assurance or regulatory compliance role in the pharmaceutical industry.
- Skills: Strong understanding of cGMP regulations, quality systems, and regulatory requirements.
- Communication: Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.