Executive - Quality Control, Pharma

Zentiva; India; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Zentiva in Ankleshwar is seeking an Executive - Quality Control to lead analytical testing in a GMP/GLP environment. You will perform sampling and analysis of materials, finished products, and process samples, while supporting method validation and compliance with quality directives.

The role requires an M.Sc in Organic/Analytical Chemistry or B.Pharm with 5–8 years of pharma/API experience, GMP/GLP knowledge, and strong coordination and data-handling skills.

Qualifications

• M. Sc in Organic/Analytical Chemistry or B. Pharm with 5–8 years of experience as an analyst in Pharmaceuticals/API industry.
• GMP and GLP knowledge is required.
• Good coordination and communication skills plus analytical ability.

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 instruments such as HPLC, GC, UV/IR, dissolution tester, auto-titrator, polarimeter, etc.
• Maintain Good Laboratory Practice and calibrate/maintain lab equipment.
• Prepare SOPs and analytical test records; manage reference and working standards.
• Arrange control samples and record maintenance; participate in investigations of out-of-spec results.
• Maintain laboratory raw data related to testing activity.
• Perform analytical method validation and cleaning validation per protocol.
• Coordinate with production and warehouse for analytical activities; ensure HSE compliance.
• Identify and report unsafe conditions and support other departmental projects.

Skills

GMP/GLP knowledge

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