Executive - Quality Control, Pharma

Zentiva S.A.; Ankleshwar; On-site; INR 600,000 - 900,000; Full time

Job summary

Zentiva S.A. – Executive – Quality Control in Ankleshwar, Gujarat, India, is responsible for implementing quality control activities in a GMP/GLP environment and ensuring product quality meets customer requirements.

The role involves sampling and analysis of materials and products, validation activities, calibration of laboratory instruments, and maintainingLab records. Collaboration with production, adherence to HSE guidelines, and participation in investigations are key aspects of this

Qualifications

• 5-8 years of experience as an analyst in the Pharmaceuticals / API industry.
• GMP & GLP knowledge required.
• Strong coordination and communication skills.
• Knowledge of LIMS & QMS.

Responsibilities

• Perform timely sampling and analysis of raw material, bulk product, intermediates, finished goods and other samples.
• Analyze Stability, process validation samples and Cleaning Validation.
• Operate laboratories instruments such as HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter.
• Calibrate and maintain lab equipment; assist in qualification of equipment.
• Prepare SOPs and Analytical Test records; manage reference standards and reagents.
• Investigate out-of-specification results and maintain lab data records.
• Coordinate with production and warehouse for analytical activities; ensure HSE compliance in QC lab.
• Identify unsafe conditions and report hazards; undertake additional assignments as needed.

Skills

Coordination

Communication

Analytical ability

Education

M. Sc (Organic / Analytical Chemistry) / B. Pharm

Tools

LIMS

QMS

Job description

Position Title: Executive – Quality Control

Qualification and Experience:

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.

- Good 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.

Location information: Ankleshwar, Gujarat, India