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Zentiva Group, a.s.
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Executive - Manufacturing Science and Technology (MST)

Executive - Manufacturing Science and Technology (MST)

Zentiva Group, a.s.

0 - 7 years

0 Lacs

ankleshwar gujarat

Posted:1 week ago| Platform: SimplyHired logo

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Skills Required

master's degree analysis skills apis manufacturing communication skills

Work Mode

On-site

Job Type

Full Time

Job Description

Position Title: Executive : Manufacturing Science and Technology (MST)

Qualification and Experience:

POST GRADUATE IN CHEMISTRY/PHARMACY Experience: 0-7 years of Experience as an analyst/Development technologist in the Pharmaceuticals / API industry. GMP & GLP knowledge

Job overview:

Providing analytical support for Chemistry activities ensuring compliance to regulatory, group directives, quality requirements, safety standards to fulfill the organization’s objective, living Group’s Values and Code of Ethics

Responsibilities:

Analytical method validation:

Analytical method Development

Analytical method transfer, Analytical method validation

CMC activity:

Sampling & testing of Process water, Raw materials, Intermediates, APIs, stability samples, hold time study samples & Cleaning validation samples

Sending samples to third party/customer, Preparation and approval of CoA, Generation and archival of GMP documents

Preparation of system & operational SOPs using eDMS

Maintaining inventory of laboratory reagents and chemicals

Providing analytical support to pilot plant in case of deviation investigation

Co-ordination with pilot plant & PRD to provide analytical support

Investigation in case of OOS/OOT, laboratory incidence, deviation & customer complaint

Impurity & reference standard qualification, Management of change control, OOS/OOT, deviation

cGMP:

Compliance to current GMP guidelines, Follow ALCOA principal maintaining GMP data

Compliance to local and international norms (Quality/HSE)

Knowledge of change control and deviation management

Regulatory compliance

Regular Pharmacopoeia and regulatory requirement review

Training of self on quality and HSE systems.

Instrumentation:

Operation & calibration of HPLC, GC, HSGC, UPLC, UV, FITR, DSC & other laboratory instruments, Trouble shooting for said instrument

Co-ordination with service provider for repairing and preventive maintenance

Qualification of laboratory instruments

Management of logbooks

Other

Complying to HSE Requirements

Identifying and correcting unsafe conditions or behaviours 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

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 Analytical Method Development and validation, GMP/ GLP environment.

Location Information: Ankleshwar, Gujarat, India

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Executive - Manufacturing Science and Technology (MST)