Officer - Quality Control

3 weeks ago

Ankleshwar, India Zentiva Group, a.s. Full time

JOB PURPOSE_

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 Common SenseZ.

KEY ACCOUNTABILITIES

Testing

Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods and other samples for Pharmaceuticals.

Performing analysis of market complaints, Stability, process validation samples, Cleaning Validation of Pharmaceuticals.

Good Laboratory Practice

Performing calibration & maintenance of lab. Equipment and assisting for the qualification of laboratory equipment.

Reviewing pharmacopeias for specification preparation.

Preparing SOPs and Formats and Analytical Test Record.

Managing reference standards, working standards, laboratory reagents & chemicals.

Arranging and observing Control Samples and maintaining record.

Participating in Investigation of out of specification results, retesting and review the analysis records.

Maintaining & reviewing laboratory raw data related to testing activity. Validation

Preparing protocol for Analytical Method validation, cleaning validation and performing the validation exercise as per the protocol.

Management of laboratory Consumables

Identifying and planning requirement for laboratory consumables and monitoring the stock of chemical, spares, glassware and printed material.

Co ordination

Coordinating with production, and warehouse for analytical activities.

Other

Compliance to HSE Requirements for QC Laboratory

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.

**REQUIREMENTS**:
Education / Experience

Post Graduate in Science (Organic or Analytical Chemistry )

0-2 years in a Pharmaceutical Company.

Technical skills &

Competencies / Language
- Analytical ability
- Trouble shootings
- Co ordination
- Communication

Behavioural Competencies

(LEAD and others)
- SuperpowerZ
- Responsible, Fast, Lean, Inclusive ,Creative, Connected

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