Zentiva

Produces branded generic pharmaceuticals in Europe

Executive – Quality Control - Pharma

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeAnkleshwar, Gujarat, IndiaNo salary listedIn-person

About the Job

Requirements

A Master of Science in Organic Chemistry or Analytical Chemistry, or a Bachelor of Pharmacy degree.
Five to eight years of experience as an analyst in the pharmaceuticals or active pharmaceutical ingredient industry.
Knowledge of Good Manufacturing Practice and Good Laboratory Practice.
Knowledge of Laboratory Information Management Systems and Quality Management Systems.
Good coordination and communication skills.
Analytical ability.

Responsibilities

Implement quality control activities at Ankleshwar in accordance with regulatory and global quality directives and health, safety, and environment guidelines, using resources effectively to ensure consistent product quality and meet customer requirements.
Perform timely sampling and analysis of raw materials, bulk products, intermediates, finished goods, and other samples.
Analyze stability, process validation, and cleaning validation samples.
Handle laboratory instruments including high-performance liquid chromatography, gas chromatography, ultraviolet and infrared spectrophotometers, dissolution testers, auto-titrators, and polarimeters.
Perform calibration and maintenance of laboratory equipment and assist with equipment qualification.
Prepare standard operating procedures, formats, and analytical test records.
Manage reference standards, working standards, laboratory reagents, and chemicals.
Arrange and observe control samples and maintain records.
Participate in investigations of out-of-specification results.
Maintain laboratory raw data related to testing activities.
Perform analytical method validation and cleaning validation according to protocols.
Coordinate analytical activities with production and warehouse teams.
Comply with health, safety, and environment requirements for the quality control laboratory.
Identify and correct unsafe conditions or behaviours and promptly report other potentially hazardous situations.
Carry out other assignments or projects as instructed by the department head to meet organizational objectives and priorities.

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

About the Company

Zentiva

Produces branded generic pharmaceuticals in Europe

Zentiva makes branded generic medicines for European markets. Its products are off-patent drugs reformulated and marketed under Zentiva’s brands, delivering the same active ingredients and dosage as original medicines at lower prices. It differentiates itself through a long history as an independent platform under private equity, with a growth strategy built on acquiring brands to expand its European footprint. The goal is to become a leading European branded generics platform and improve access to affordable medicines across its markets.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Prague, Czechia
Founded: 2003

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