Quality Assurance Specialist

MSD Malaysia; Warszawa; Hybrid; PLN 120,000 - 180,000; Full time

Job summary

A leading bio-pharmaceutical company in Warsaw is seeking a Quality Assurance Specialist. The role involves ensuring compliance with quality regulations and managing the local Quality Management System. Candidates must possess a Master's Degree in Pharmacy and have at least 2 years of experience, along with proficiency in Polish and English. The position offers a hybrid work model and ample development opportunities.

Benefits

High standard of work tools

Great development opportunities

Qualifications

• Minimum 2 years of experience in a pharmaceutical wholesaler or pharmacy.
• Very good Polish skills as well as good English skills.

Responsibilities

• Act as the deputy of the Quality Responsible Person.
• Support in the implementation and maintenance of the local Quality Management System (QMS).
• Coordinate daily operations in the local Quality Management System.

Skills

Accountability

Adaptability

Aseptic Manufacturing

cGMP Compliance

Data Analysis

Decision Making

Documentation Review

FDA Regulations

Interpersonal Relationships

Laboratory Quality Control

Quality Inspections

Regulatory Compliance

Technical Writing

Education

Master's Degree in Pharmacy

Tools

MS Office

Job description

Quality Assurance Specialist page is loaded## Quality Assurance Specialistremote type: Hybridlocations: POL - Mazowieckie Wojewodztwo - Warsaw (Trade Center): POL - Poland - Polandtime type: Full timeposted on: Posted Todaytime left to apply: End Date: November 3, 2025 (27 days left to apply)job requisition id: R368771Job 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 candidate's 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 You’ll 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:*** Master's 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 licenceWe 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:**Accountability, Adaptability, Aseptic Manufacturing, cGMP Compliance, Data Analysis, Decision Making, Documentation Review, Documentations, FDA Regulations, Interpersonal Relationships, IS Audit, Laboratory Operations, Laboratory Quality Control, Quality Inspections, Quality Operations, Regulatory Compliance, Regulatory Inspections, Technical Writing**Preferred Skills:**Current Employees applyCurrent Contingent Workers apply**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:**Regular**Relocation:****VISA Sponsorship:****Travel Requirements:****Flexible Work Arrangements:**Hybrid**Shift:****Valid Driving License:****Hazardous Material(s):****Job Posting End Date:**11/3/2025**\*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.**