QA Specialist ESO

1 week ago

Ankleshwar India Zentiva Full time

Job Description

Be a part of the winning culture

At Zentiva, we are a team of 4,800 unique talents bonded together by our common mission. We believe our diversity is a source of great energy and strength, and we create a work culture and ethics where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking a balanced team across the company we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love.

What Would Be Your Main Responsibilities

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 type and scope of work.

We Need You To Have

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

It is crucial for us to have satisfied employees. Therefore, we can offer you the following:

- Competitive salary;
- Additional benefit package;
- Hybrid mode of work;
- International working environment and a passionate team of professionals;
- Continuous Learning & Development opportunities.

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