Quality Assurance Specialist
Quality Assurance Specialist
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Job Description
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!
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 (Gwny 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.
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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability Aseptic Manufacturing cGMP Compliance Data Analysis Decision Making Documentation Review Documentations FDA Regulations Interpersonal Relationships IS Audit Laboratory Operations Laboratory Quality Control Management Process Quality Inspections Quality Operations Regulatory Compliance Regulatory Inspections Technical WritingPreferred Skills:
Job Posting End Date:
08/5/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
