CEE Quality Manager, Responsible Person

24 godzin temu


Warszawa, Polska HAYS POLAND Sp. z o.o. Pełny etat

CEE Quality Manager, Responsible Person

lokalizacja: Warszawa (mazowieckie)

numer referencyjny: 1190570/jobs.pl

forma zatrudnienia: Pełny etat

** Functions, Duties, Tasks:**

- Oversee affiliate operations to ensure full compliance with GxP standards, company quality policies, and local regulations.
- Collaborate closely with affiliate leaders to proactively identify and address issues.
- Drive continuous improvement by conducting routine self-assessments, managing CAPAs (Corrective and Preventive Actions), and implementing a Quality Plan.
- Take responsibility for local product quality issues, escalating concerns to regional quality leadership and affiliate management, and leading any necessary local actions (e.g., recalls, counterfeit product management).
- Ensure accurate completion of operational quality tasks, including deviation management, change control, procedure review/approval, and maintenance of the Quality Plan.
- Work with the Responsible Person (or act as one) to verify compliance with Wholesale Distribution Authorization requirements.
- Oversee distribution, product release, and warehousing in alignment with company and regulatory standards, including management of returns, recalls, and product reintegration.
- Initiate notifications to management and implement product holds or quarantines as necessary.
- Analyze and report on Quality metrics, identify trends, and lead continuous improvement initiatives related to deviations and customer complaints.
- Develop and coach team members through impactful training programs, performance evaluations, and leadership development.
- Adhere to company policies on Quality, Code of Conduct, anti-discrimination, and Health, Safety, and Environment (HSE).
- Manage GMP+ tasks such as quality manual maintenance, annual inspections, mock recalls, and participation in HACCP teams.
- Supervise the Central and Eastern Europe (CEE) Quality Team.

**Responsibilities as Responsible Person (RP):**

- Ensure the implementation and maintenance of a quality management system.
- Oversee authorized activities, ensure accurate records, and implement training programs.
- Manage and execute product recalls effectively.
- Handle customer complaints and approve suppliers and customers.
- Approve subcontracted activities affecting Good Distribution Practices (GDP).
- Conduct regular self-inspections, ensure CAPAs are implemented, and maintain records of delegated duties.
- Decide on the final status of returned, rejected, or falsified products, including approval for returns to saleable stock.
- Comply with additional legal requirements for certain products and manage deviations by implementing and monitoring CAPAs.

**Requirements:**

- Master’s degree in Pharmacy or Veterinary Medicine.
- Fulfillment of the requirements outlined in Article 84 of the Polish Pharmaceutical Act of 2001 to qualify as a Responsible Person in Poland.
- Proven leadership and influence in a cGxP (current Good Practices) environment, ideally in a Quality role.
- Ability to lead and collaborate effectively, with experience in stakeholder management.
- Strong communication, presentation, and facilitation skills.
- Skilled in regulatory inspections, audit management, and responses to health authorities.
- Analytical and investigational expertise.
- Excellent organizational and strategic planning skills.
- Fluency in Polish and English (written and spoken).
- Knowledge of inventory management is a plus.

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361.

hays.pl

Hays Poland sp. z o.o. jest agencją zatrudnienia nr 361



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