Quality Manager

Quality Manager

Role:

Responsible person according international and local laws for maintaining a Quality System based on applicable Good Distribution Practices principles and Corporate Quality standards of medicinal products and medical devices.

Activities and responsibilities:

1. Be the Responsible Person as per GDP requirements.


2. To assure distribution activities (procurement, storage, complaints management…), to be in compliance with Good Distribution Practices regulation.


3. Elaborate, approve and keep updated relevant SOPs and records.


4. Responsible for the local batch release of medicinal products and medical devices in compliance with and local requirements.


5. Responsible to approve returns to saleable stock.


6. Overview of GDP subcontracted activities and service providers (initial and regular requalification, audits, CAPA follow up, quality agreements, performance, etc…)


7. Review of publicity messages and promotional material from a Regulatory perspective.


8. Responsible and local contact for pharmacovigilance.


9. To obtain and keep updated all the licenses necessary for products and/ordistribution activities.


10. Regulatory Affairs local contact person with local authorities and Headquarters.


11. Implementation, maintenance and continuous improvement of a quality system according to GDP regulations and Corporate Quality standards: record and coordination of complaints, deviations, CAPAs, change control, risk analysis, internal and external audits.


12. Host Authorities Health inspections and internal, corporate or customer audits


13. Liaison with National Regulatory Authority of the country and neighboring countries.


14. Liaising with other parties including with Quality personnel at manufacturing sites, Logistics and Customer Services, headquarters, etc.


15. Ensure training programmes are implemented, maintained, and effective for all relevant staff.


16. Lead and coordinate recall operations


17. Other applicable by local laws.

Academic requirements:

Degree in Pharmacy.

Knowledge skills and abilities:

• Strong resourcefulness and ability to proactively seek information, engage with stakeholders and independently resolve issues.


• Excellent organizational skills.


• Excellent attention to detail.


• Team Player and strong interpersonal skills.

Professional Experience:

• 5 years’ experience managing a Quality System in a similar position,


• Experience in GDP.


• In-depth knowledge of Polish and EU legislation applicable to medicinal products and medical devices.


• Regulatory Affairs experience preferred.

Scope:

Countries associated to the affiliate (Poland and other Baltic countries).

IT:

• Proficient in Microsoft Office (especially Excel and Word).


• SAP user level.

Languages:

• Local language


• ENGLISH: advanced level.

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Location: EMEA : Poland : Warsaw:Polska 

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