JOB TITLE Assistant Manager- Quality Control, Chemistry
REQUIREMENTS
Education / Experience Post Graduate in Science (Organic or Analytical Chemistry ) 8 to 10 years in chemical & instrumental testing laboratory with exposure to GMP, GLP.
Technical skills &
Competencies / Language · Technical competence · Leadership skills · Analytical ability · Planning ability · Communication skills · Problem solving
JOB PURPOSE
Generic To perform QC activities in order to ensure quality of products and services and maintain related documentation to adhere to Quality operations and regulatory requirements. All above activity shall be done living Group’s Values and Code of Ethics.
KEY ACCOUNTABILITIES
1. Testing
1.1. Performing and organizing timely analysis of finished goods, stability samples, raw material, intermediate
and other samples for Chemistry.
1.2. Performing and organizing analysis of market complaints, Stability, process validation, Cleaning
Validation samples.
2. Valuable Laboratory Practice
2.1. Performing and organizing calibration / maintenance of lab.
Equipment and assisting for the qualification
of laboratory equipment.
2.2. Reviewing pharmacopeias for specification preparation.
2.3. Preparing SOPs, Formats, Specification, Analytical Test Record and other documents.
2.4. Managing reference standards, working standards, Laboratory chemicals & reagents.
2.5. Managing instrument laboratory with reference to spares, maintenance etc.
2.6. Managing Control Samples and related record.
2.7. Approval / Rejection of Raw Materials, Packaging materials, in process materials, Bulk Finished products
and bulk medical device.
2.8. Investigating out of specification results, retesting and review the analysis records.
2.9. Maintaining & reviewing laboratory raw data and log book related to testing activity.
2.10. Responsible for reviewing the chromatographic data.
2.11. Management of LIMS and static data
3. Quality, HSE and Compliance
3.1. Adhere to current GMP guidelines
3.2. Followi