Quality Assurance Specialist
Błonie woj. mazowieckie / system pracy hybryda
UoP
Dla jednej z hurtowni farmaceutycznych poszukujemy osoby na stanowisko:
Quality Assurance Specialist
Essential duties and responsibilities :
As a QA Specialist, the main duties and responsibilities are as follows:
- maintaining appropriate contacts with Regulatory Affairs, Pharmacovigilance, PMS, W&D, TS, Business, and Third Parties.
- ensuring compliance of local processes and procedures (local Quality Management System – QMS) with applicable corporate requirements (Corporate Quality Manual, EN ISO 9001, EN ISO 13485) and with the requirements of Polish laws
- supporting the successful outcome of internal/external audits.
- handling of following processes: product quality complaints, hold and recall, supplier qualification, non-conformances and CAPA, change control process, training, risk management, auditing, in Poland and SEE markets.
- participating in quality and business projects in Poland and SEE markets.
As a deputy of Responsible Person in GDP area in pharmaceutical wholesaler according to the Polish regulation:
acting as the responsible person in the GDP area in the pharmaceutical wholesaler as required by the Polish pharmaceutical law and in accordance with the tasks delegated by the Responsible Person in his/her absence
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 pharmacy.
- Valid License to practice the pharmacist profession.
- Proven professional experience of at least 2 years in a pharmaceutical wholesaler or pharmacy
- 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.
- Package of benefits including Private medical care, Life Insurance, Multisport card.
- Cafeteria/lunch cards.
- Educational support.