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Assistant Manager Quality Control, Pharmaceuticals
Zentiva
Ankleshwar, IND
Full-time
Manager · 8–10 years experience
Onsite
Discovered 3 weeks ago
Full Job Posting
REQUIREMENTS
- Education / Experience
- Post Graduate in Science (Organic or Analytical Chemistry) or B.Pharm/M.Pharm
- 8-10 years in chemical & instrumental testing laboratory with exposure to GMP, GLP
- Technical skills &
- Competencies / Language
- Analytical ability
- Trouble shootings
- Co ordination
- Communication
- Problem solving
- JOB PURPOSE
- Generic
- Implement quality control activities for Pharmaceuticals 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 with customers’ requirements, living Group’s Values and Code of Ethics.
- KEY ACCOUNTABILITIES
- Testing
- Performing and organizing timely analysis of raw material, bulk product, intermediates, finished goods and other samples for Pharmaceuticals.
- Performing and organizing analysis of market complaints, Stability, process validation, Cleaning Validation samples of Pharmaceuticals.
- Good Laboratory Practice
- Performing and organizing calibration / maintenance of lab. Equipment and assisting for the qualification of laboratory equipment.
- Reviewing pharmacopeias for specification preparation.
- Preparing SOPs, Formats, Specification, Analytical Test Record and other documents.
- Managing reference standards, working standards, Laboratory chemicals & reagents.
- Managing instrument laboratory with reference to spares, maintenance etc.
- Managing Control Samples and related record.
- Approval / Rejection of Raw Materials, Packaging materials, in process materials, Bulk Finished products and bulk medical device.
- Investigating out of specification results, retesting and review the analysis records.
- Maintaining & reviewing laboratory raw data and log book related to testing activity.
- Responsible for reviewing the chromatographic data.
- Validation
- Preparing protocol and report for Analytical Method validation, cleaning validation and performing / organizing the validation exercise as per the protocol.
- Support testing of process validation/verification samples
- Management of laboratory Consumables
- Identifying and planning requirement for laboratory consumables and monitoring the stock of chemical, glassware and printed material.
- Coordinating with production, and warehouse for analytical activities.
- Other
- Compliance to HSE Requirements for QC operations
- Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
- Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.
- Train the subordinate for laboratory related jobs.
Technical skills &
- Competencies / Language
- Analytical ability
- Trouble shootings
- Co ordination
- Communication
- Problem solving
JOB PURPOSE
- Generic
- Implement quality control activities for Pharmaceuticals 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 with customers’ requirements, living Group’s Values and Code of Ethics.
- KEY ACCOUNTABILITIES
- Testing
- Performing and organizing timely analysis of raw material, bulk product, intermediates, finished goods and other samples for Pharmaceuticals.
- Performing and organizing analysis of market complaints, Stability, process validation, Cleaning Validation samples of Pharmaceuticals.
- Good Laboratory Practice
- Performing and organizing calibration / maintenance of lab. Equipment and assisting for the qualification of laboratory equipment.
- Reviewing pharmacopeias for specification preparation.
- Preparing SOPs, Formats, Specification, Analytical Test Record and other documents.
- Managing reference standards, working standards, Laboratory chemicals & reagents.
- Managing instrument laboratory with reference to spares, maintenance etc.
- Managing Control Samples and related record.
- Approval / Rejection of Raw Materials, Packaging materials, in process materials, Bulk Finished products and bulk medical device.
- Investigating out of specification results, retesting and review the analysis records.
- Maintaining & reviewing laboratory raw data and log book related to testing activity.
- Responsible for reviewing the chromatographic data.
- Validation
- Preparing protocol and report for Analytical Method validation, cleaning validation and performing / organizing the validation exercise as per the protocol.
- Support testing of process validation/verification samples
- Management of laboratory Consumables
- Identifying and planning requirement for laboratory consumables and monitoring the stock of chemical, glassware and printed material.
- Co ordination
- Coordinating with production, and warehouse for analytical activities.
- Other
- Compliance to HSE Requirements for QC operations
- Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
- Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.
- Train the subordinate for laboratory related jobs.
About Zentiva
Pharmaceutical Manufacturing5400 employees
Private European pharmaceutical company developing, manufacturing, and supplying affordable generic, specialty, and over-the-counter medicines.
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