Country Quality Assurance Specialist

2 tygodni temu

Błonie, Mazovia, Polska Baxter Pełny etat

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Essential duties and responsibilities

As a Responsible Person in GDP area in Baxter's Polska pharmaceutical wholesaler according to the Polish regulation:

personally, fulfilling the duties of the Responsible Person. release of products for distribution in Poland/region after verification of their compliance with all applicable requirements (in cooperation with the manufacturing site), in particular transport and storage conditions in the GDP area. contact person with local authorities.

As a CQA Senior Officer Poland, the main duties and responsibilities are as follows:

maintaining appropriate contacts with Regulatory Affairs, Pharmacovigilance, PMS, W&D, TS, Business, and Third Parties. ensuring that the following CQA processes and procedures are "in place" and "in use" (Post Market Surveillance (PQC, MDR, FA), product traceability, Quality System implementation and maintenance). supporting the successful outcome of internal/external audits. ensuring compliance of local processes and procedures (local Quality Management System - QMS) with applicable corporate requirements (Coporporate Quality Manual, EN ISO 9001, EN ISO and with the requirements of Polish laws. supporting the CQA Senior Manager in ensuring that the CQA processes are "in place and in use" in Poland, and the region - ECEMEA.

Qualifications

Ability of understanding country specific regulations and general quality requirements. Ability to liaise with different functions involved: e.g. PVS, TS, Regulatory. Ability to liaise with multicultural teams. Very good spoken and written English and Polish. Good interpersonal and communication skills. Computer skills (Word, Excel, Power Point, Outlook, corporate software).

Education and/or experience

University degree in Scientific field ( Pharmacy ). Valid License to practice the pharmacist profession. Proven 3-5 years of relevant work experience. Approval from the relevant Pharmacist Chamber.

We offer

Fixed-term contract for 3 months and after successful completion the next preferred type of contract is for an indefinite period. Competitive salary, annual bonuses, recognition award program. Corporate culture based on our values: collaboration, speed, courage and simplicity. Possibilities for development on a personal and professional level in one of the leading global MedTech companies. Package of benefits including Private medical care (Lux Med), Life Insurance, Multisport card. Bax4U - cafeteria/lunch cards (300 PLN). PPE program with very attractive conditions available for each employee after 3 months. Educational support: fully covered language courses (English or other languages according to business needs), financial certifications (ACCA, CIMA). Co-financing of holidays and an additional 2 days off from work annually. Employee Stock Purchase Plan.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

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