M. Sc (Organic / Analytical Chemistry) / B. Pharm with 5 - 8 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge
Job overview:
- Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements.
Responsibilities:
- Analysis:
Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples. Performing analysis of Stability, process validation samples, and Cleaning Validation.
Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc.
- Positive Laboratory Practice
Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment. Knowledge on the preparation of SOPs and Formats and Analytical Test records.
Managing reference standards, working standards,
laboratory reagents & chemicals.
Arranging and observing Control Samples and maintaining the record.
Participating in the Investigation of out-of-specification results.
Maintaining laboratory raw data related to testing activity.
- Validation
Performing Analytical Method validation, cleaning validation as per the protocol.
- Other
Coordinating with production and the warehouse for analytical activities Compliance to HSE Requirements for QC laboratory.
Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations.
Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities.
Requirements
- GMP & GLP knowledge
- Good coordination & communication skills.
- Analytical ability
- Knowledge on LIMS & QMS
What makes this position unique?
- This position will provide good exposure to work in GMP/ GLP environment.