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Mendine Pharmaceuticals
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SENIOR TECHNICAL OFFICER - QUALITY ASSURANCE

SENIOR TECHNICAL OFFICER - QUALITY ASSURANCE

Mendine Pharmaceuticals

6 - 9 years

8 - 11 Lacs

kolkata

Posted:-1 days ago| Platform:

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Skills Required

product quality batch manufacturing internal audit pharma process validation packaging nda data integrity risk management document control

Work Mode

Work from Office

Job Type

Full Time

Job Description

Technical: cGMP compliance, QA/QMS, Quality Risk Management, Process Validation, Cleaning Validation, APQR, BMR/BPR preparation and review, Packaging material/specification management, Dossier/NDA preparation, Change Control and Deviation Management, Technology transfer, Internal auditing, Documentation control and data integrity (ALCOA+).
Soft: Attention to detail, strong documentation and communication skills, cross-functional collaboration, problem-solving, compliance mindset. Domain: Pharmaceutical manufacturing and regulatory inspection support. Quality Risk Management; Batch Manufacturing Record (BMR) preparation; Process Validation; Packaging Material Specification preparation; Annual Product Quality Review (APQR); Cleaning Validation; Batch card preparation; Dossier preparation; Change Control Management; Deviation Management; Endorse documents preparation; New Drug Application; Technology transfer

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Mendine Pharmaceuticals

Biotechnology / Pharmaceuticals

Bioville

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SENIOR TECHNICAL OFFICER - QUALITY ASSURANCE