Q A Manager (Pharma)

Job Description

Large, public listed, specialty chemicals & pharma intermediates manufacturer in Mumbai

1.     Oversee the documentation involved in technology transfer from lab batch to exhibit batch, pilot batch and plant batch.

2.     Preparation and modification of new and existing SOPs as per the statutory requirement.

3.     Preparation of all documentation such as DMF, stability study, CoA, MoA for all products.

4.     Maintain the area and equipment as per the cGMP protocols

5.     Maintain batch production records as per cGMP and FDA protocols

6.     Coordinate IQ/OQ for any new equipment or system

7.     Train subordinates and production teams regarding operation and cleaning SOP as per pharma guidelines

8.     Design, plan and execute the compliance process for all new pharma excipient products.

9.     Perform online documentation for all production batches and hold batches

10.  Managing change control for all plant processes

11.  Batch analysis, quality control and preparation of COA for all incoming and outgoing raw materials and finished goods. 

Skills