IPQA Officer
Lyka Labs Ltd
Ankleshwar, Gujarat, India
Posted on 12-02-2025
1 Vacancy
Description
- Develop, implement, and execute validation protocols for quality systems, equipment, and processes to ensure compliance with regulatory requirements.
- Prepare and review validation documents such as protocols, reports, and qualification records to ensure accuracy and completeness.
- Conduct risk assessments and define acceptance criteria to support the validation process.
- Perform equipment, system, and process validations, ensuring compliance with GMP, FDA, ISO, and other regulatory standards.
- Collaborate with cross-functional teams (e.g., Production, R&D, Engineering) to ensure validation activities align with quality assurance and operational requirements.
- Conduct periodic reviews and revalidation activities to ensure systems and processes continue to meet performance standards.
- Investigate deviations, failures, and non-conformances during validation activities, implementing corrective and preventive actions (CAPA).
- Maintain comprehensive documentation of all validation activities, ensuring records are accurate, up-to-date, and audit-ready.
- Ensure all validation activities comply with company procedures and regulatory guidelines.
- Provide training and support to staff on validation techniques, QA procedures, and regulatory compliance standards.
Category
Pharmaceuticals
Functional Area
Pharma Quality Assurance (QA)
Key Skills
Good CommunicationAttention to DetailDecision MakingProblem Solving Skills
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