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Regulatory Compliance Change Assessor - Sr Associate
ConfidentialHyderabad / Secunderabad, Telangana26 days ago
Job descriptionReviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies.
Basic Qualifications :
- Master's degree
- Bachelor's degree and 2 years of manufacture, QA / QC, or regulatory CMC in the Pharmaceutical / Biotechnology industry
- Associate's degree and 6 years of manufacture, QA / QC, or regulatory CMC in the Pharmaceutical / Biotechnology industry
- Diploma and 8 years of manufacture, QA / QC, or regulatory CMC in the Pharmaceutical / Biotechnology industry
- Degree in Life Science discipline
- Regulatory CMC specific knowledge & experience
- Understanding and application of principles, concepts, theories and standards of scientific / technical field
- Experience in manufacture, testing (QC / QA or clinical), or distribution in Pharmaceutical / Biotech industry
Preferred Qualifications :
Skills Required
Change Control, Compliance, Life Sciences, Pharmaceutical, Quality Assurance
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Associate Compliance • Hyderabad / Secunderabad, Telangana
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