Quality Assurance Specialist

Job Description

If you want to:

• Join a multi- award winning leading bio-pharmaceutical company

• Be at the center of innovation

• Be part of In-Market Quality (IMQ)

Apply today!

The preferred candidates current location is Warsaw or Łódź.

Position overview:

Ensuring compliance with all quality and compliance regulations for the distribution and wholesale of pharmaceuticals in accordance with the guidelines of Good Distribution Practice (GDP) as well as the relevant local laws (the Pharmaceutical Law Act and implementing acts to the Pharmaceutical Law Act and any additional requirements specified in separate regulations).

What Youll Do:

Includes but is not limited to:

• Act as the deputy of the Quality Responsible Person

• Support in the implementation and maintenance of the local Quality Management System (QMS)

• Coordination of daily operations in the local Quality Management System including SOP management audits & self-inspections training management and documentation deviation and CAPA management change controls quality risk management monitoring of outsourced activities

• Responsibility for GDP-compliant execution of customer qualifications as well as handling product quality complaints within the DPOC process

• Subject Matter Expert for various internal systems concerning for example archiving or training or document management

• Close cooperation with colleagues from logistics and the logistics service provider especially regarding GDP-compliant distribution

• Deputy contact person for the local authority (Główny Inspektorat Farmaceutyczny) on GDP-relevant topics

• Support in the local coordination and execution of recalls

• Interact with a regional Cluster and a Global Quality Organization

You should apply if you have:

• Masters Degree in Pharmacy and minimum 2 years of experience in a pharmaceutical wholesaler or pharmacy required

• Very good Polish skills as well as good English skills

• Excellent knowledge of MS Office applications

We encourage you to apply especially if you have:

• Ability to work in a cross-functional team with local and regional colleagues effectively

• A quick grasp and the ability to make well-founded decisions even under pressure

• Cat. B driving licence

We set financial rates based on regular market reviews. We care about equality and comfort. We provide a high standard of work tools and great development opportunities.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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