Quality Assurance Specialist

2 weeks ago


Davangere, Karnataka, India beBeeQuality Full time ₹ 15,00,000 - ₹ 20,00,000

Our organization is seeking a diligent Quality Assurance specialist to oversee and enhance our in-process quality assurance procedures. This role will be responsible for ensuring compliance with cGMP, SOPs, and regulatory requirements through meticulous review and approval of batch manufacturing records, packaging records, and in-process control data.

The successful candidate will collaborate closely with on-site teams to resolve discrepancies or missing documentation before batch release, leveraging their expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.). They will also compile, review, and analyze electronic data for Annual Product Quality Review reports, identify trends or recurring issues, and prepare remote review summaries for cross-functional teams.

Apart from these responsibilities, the ideal candidate will assess change control proposals, evaluating potential impacts on validation, processes, and regulatory compliance, as well as conduct remote review of deviation reports, root cause analyses, and corrective action proposals, and track deviation trends for periodic reporting.

To excel in this position, the candidate should possess in-depth knowledge of sterile injectable manufacturing processes and aseptic techniques, strong analytical and problem-solving skills, effective communication and documentation skills, and the ability to manage cross-functional teams and prioritize tasks.

A Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field is mandatory, while proficiency in QMS tools and software is highly desirable.



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