JOB DESCRIPTION

Job Title: General Manager – QA & QC
Location : Tarapur
Experience : 15 – 18 yrs
Qualification : Ph.D or M.Sc. (Org. / Anal.)

Purpose of Job:
Implement the QA & QC policies at the Plant for meeting the Company’s Business Plan and develop systems for achieving consistency in implementation of various regulatory compliances like USFDA, EDQM, WHO  Geneva.

JOB PROFILE :

1. Planning, implementing and prioritizing Quality Control Systems and jobs as per plant requirements for Raw Materials, Packing Materials, In-process and Finished Products in coordination with R&D, Pilot Plant and QA.
2. Establishing specification and Method of Analysis of Raw Materials, Packing materials, In-process and Finished Products as per norms.
3. To train Staff, Operators and update their skills (cGMP, Safety, etc).
4. Ensure completeness in documentation and validation of process and analytical methods as per cGMP requirements.
5. To maintain discipline at all levels 
6. Coordination with Maintenance, Stores, Admn., Safety, Production and Corporate functions.

Desired Profile:
Min 15 years of experience in QA of API manufacturing. Must have faced international audits like WHO Geneva, EDQM, MHRA, USFDA, Customer’s Audits, etc. in a leading role. Should have experience of closely working with Regulatory Affairs.