Quality Assurance Specialist

MSD; Poland (ME); Remote; USD 60,000 - 80,000; Full time

Job summary

A leading bio-pharmaceutical company is seeking a qualified candidate to ensure quality and compliance in pharmaceuticals. The role includes acting as a deputy contact for local authorities, support in quality management systems, and executing customer qualifications. Ideal candidates hold a Master's in Pharmacy and have experience in a pharmaceutical environment. Strong Polish and English language skills are required.

Qualifications

• Master's Degree in Pharmacy with minimum 2 years of experience in a pharmaceutical wholesaler or pharmacy.
• Very good Polish skills and good English skills.
• Excellent knowledge of MS Office applications.

Responsibilities

• Ensure compliance with all quality and compliance regulations for distribution of pharmaceuticals.
• Act as the deputy of the Quality Responsible Person.
• Support in the implementation and maintenance of the local Quality Management System.

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!

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 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:

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:

EEO statement: Merck & Co., Inc. is an equal employment opportunity employer.