
Senior Pharmaceutical QA Executive
2 days ago
We are seeking a skilled Quality Assurance Specialist to support our daily quality assurance activities in a GMP-regulated pharmaceutical facility. The role will focus on documentation review, QA activities, and ensuring compliance with regulatory standards.
Main Responsibilities:
- Review batch manufacturing and packing records by examining the accuracy of product information and adhering to regulatory requirements.
- Line clearance for production and packaging activities involves conducting thorough checks to ensure all necessary documents are complete and accurate.
- Support in handling deviations, change controls, CAPA, and incident reports by collaborating with cross-functional teams to resolve issues efficiently.
- Ensure compliance with cGMP and Revised Schedule M requirements by maintaining awareness of regulatory updates and implementing changes as needed.
- Participate in in-process checks and quality monitoring to guarantee that products meet quality and regulatory standards.
- Assist in preparation and review of SOPs, logbooks, and other controlled documents by providing expertise on document control and formatting.
- Support internal audits and regulatory inspection readiness by coordinating efforts to ensure seamless interactions with auditors and inspectors.
Required Skills and Qualifications:
- Bachelor's degree in Life Sciences or related field
- 2-4 years of experience in QA in a pharmaceutical company
- Strong understanding of cGMP and QMS principles
- Excellent documentation and communication skills
Benefits:
- Opportunity to work in a dynamic and growing organization
- Collaborative and supportive team environment
- Professional growth and development opportunities
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