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ESO QA specialist

ESO QA specialist

Zentiva

0 - 5 years

0 Lacs

ankleshwar gujarat

Posted:3 days ago| Platform: Indeed logo

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Skills Required

management portfolio assessment evaluation stability compliance maintenance support mdr regulations audit audits monitoring communication negotiation collaborative

Work Mode

On-site

Job Type

Full Time

Job Description

Position title: ESO QA Specialist

University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
Minimum of 5 years in a similar role or equivalent experience in a GMP-related environment

Job location - Ankleshwar, Gujarat, India

MISSION STATEMENT

To ensure the quality lifecycle management for dedicated, subcontracted, product portfolio. Qualified auditor.

MAIN ACCOUNTABILITIES AND DUTIES

Operational skills

Operational quality management of a dedicated product portfolio which includes:

Quality management of deviation and complaint records and their related CAPAs
Assessment and management of change controls
Edition of QA Agreements with Zentiva third parties and subcontractors
Collection and evaluation of PQRs and stability data
Compliance evaluation of Third Parties and products
Maintenance of product database
Collection and review of CoA/CoC
QA support of product launches and transfers
GMP, GDP, MDR, HACCP, Food Supplements and Cosmetics regulations and legislations

Auditing

Prepare audit and audit plans
Conduct and participate to external audits
Evaluation of audit reports
Participate to internal audits and inspections

KPI monitoring and reporting

Other tasks may be performed under the direction of the Manager within the agreed-upon type and scope of work.

REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS

University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
Minimum of 5 years in a similar role or equivalent experience in a GMP-related environment
Thorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirements
Management of subcontractors is an advantage
Proven track record of project management skills
Strong communication skills and negotiation strength
Proactive attitude
Problem-solving skills
Hands-on attitude, flexible and open-minded
Collaborative and team-spirited
Knowledge of IT tools
Language - English: Advanced level

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