Associate Director Quality Assurance
2 weeks ago
Reporting to the VP Quality, the Associate Director Quality Assurance will be responsible for leading the Quality Assurance team to ensure the delivery of high-quality products.
Key Responsibilities:
- Develop and implement Quality Management Systems to ensure compliance with GxP regulations.
- Lead Internal Audits to verify the adequacy of CSV deliverables and Documentation.
- Review and provide feedback on Validation Plans, Test Plans, and Qualification Scripts.
- Collaborate with the Engineering Team to resolve CAPA and RCA issues.
- Ensure Sampling of 25% of artefacts for audits.
Requirements:
- BE/ B.Tech./ MCA/M. Pharma or equivalent degree from a recognized institute.
- Minimum 15-20 years of experience in Software Development, Product Implementation, and CSV.
- Strong knowledge of GxP, 21 CFR Part 11, EU Annex 11, and ALCOA + principles.
- Lead Auditor certification on ISO 9001:2015 and ISO 27001:2013.
Preferred Qualifications:
- Excellent communication and leadership skills.
- Experience with documentation authoring, reviewing, and requirement analysis.
How to Apply:
Interested candidates can submit their resumes to shruti@hrworksindia.com.
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