Opening for Officer/executive in Regulatory Compliance @ Emcure
Opening for Officer/executive in Regulatory Compliance @ Emcure. Career @ Emcure. Chemistry & Pharma candidates are invited for Officer/executive in Regulatory Compliance post @ Emcure. Chemistry & Pharma jobs @ Emcure. Emcure hiring Chemistry & Pharma candidates @ Emcure. Check out all the details on the same below:
Emcure Pharmaceuticals Ltd. is a fast growing fully integrated Indian pharmaceutical company with global presence engaged in developing, manufacturing and marketing a wide variety of pharmaceutical products globally. Our core strength lies in manufacturing and developing differentiated pharmaceutical products in house, which we commercialize through our marketing infrastructure across geographies and relationships with multi-national pharmaceutical companies.
Job Title: Officer/executive
No. of posts: 01
Eligibility: UG -B.Pharma – Pharmacy
PG – MS/M.Sc(Science) – Any Specialization, M.Pharma – Pharmacy
Salary: INR 3,50,000 – 7,50,000 P.A.
Job Description:
- Review of documents for product life cycle management (PAS, Annual updates, CBE-30, CBE-0).
- Review of Quality Management System (QMS) documents and its effectiveness.
- Work as Regulatory Intelligence to source and facilitate regulatory guidance updates, warning letters, 483s, GMP Trends, and recall.
- Periodic monitoring of manufacturing operation during routine production activity.\
- Provide support during the regulatory inspection, third-party audit and consultants visits.
- Preparation, review, and compilation of documents for regulatory audit compliance.
- Preparation and revision of protocol, report, policies and Standard Operating Procedure (SOPs) as per requirement.
- Review of Abbreviated New Drug Applications (ANDAs).
- Trending of deficiencies and categorization, follow up on closures & CAPA
