Prepare, update and review the specifications, SOPs, policy and operating documents for analysis of materials in order to ensure alignment to predefined quality parameters and compliance to respective standards / pharmacopeia and cGMP requirements
Accountabilities
I. Prepare documents like SOPs, specifications and non-routine documentation and ensure timely availability across the site to provide support during the analysis
II. Review the latest pharmacopeial updates, supplements and amendments by evaluating the updates required in the available document to ensure the compliance with the current pharmacopoeia through consent with regulatory body
III. Review the assigned documents by referring the concern backup and pre-defined quality procedure to ensure its compliance against the quality requirements
IV. Issue documents to applicable units, by maintaining the record of the same in the issuance record (bound book) so the current version of the common document is available at the unit
V. Execute harmonization and simplification process of documents to reduce complexities in processes and ensure standardized procedures are followed
Education Qualification
M.Sc. / B. Pharma
Relevant Work Experience
2 years of experience in QC department of a pharmaceutical organization
Competencies/Skills
Communication Skills (clarity of thought, comprehension)
Likely potential for growth
Job / Product / Technical Knowledge / Pharma domain knowledge
Presentation & Interpersonal skills (If applicable)
Managerial or People Management skills
Safety awareness (If applicable)
Relevance of Previous Experience
Comprehension, Analytical & Problem solving abilities
Productivity & Result Orientation (If applicable)
Attitude
Qualification fitment
Sales drive (If applicable)
Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)
Job Location
Rangpo
Shift Hours
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