JOB DESCRIPTION

Job Title: Manager – Quality Control
Location : Tarapur & Mumbai
Experience : 8 – 10 yrs
Qualification : MSc. (Org./Ana.)

Purpose of Job:

Ensure Developing and implementing Quality System of approval or rejection of RM,PM,FP along with method of analysis as per cGMP guidelines.

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 in-house and outsource activities.
2. Developing specification and Method Analysis of Raw Materials, Packing materials, In-process and Finished Products as per norms.
3. Prepare site master file, Annual product review, Quality manual, validation master plan and SOPs related to all departments.
4. Handle internal and external audits & liaison with FDA authorities.
5. Documentation handling such as deviation, change control and OOS.
6. Training to Staff, Operators and update their skills (cGMP, Safety, etc)

Desired Profile :

Must have faced international audits like WHO Geneva, EDQM, MHRA, USFDA etc. FDA approved will be added advantage. Knowledge of QA, QC analysis and interpretation of results, cGMP and GLP and Trouble shooting analysis.Knowledge of ISO 9000/14001.