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Quality Assurance Specialist

2 months ago

London, United Kingdom MSD Full time

Job Description

As a Quality Assurance Specialist, you will be a key contributor in a team consisting of quality professionals in the Nordic countries, Ireland, and the UK. In the team, we focus on ensuring company compliance with external and internal requirements pertaining to wholesaling activities/Good Distribution Practices (GDP). You will work closely with the QRP (Quality Responsible Person) in the UK. You will also interact with a broad spectrum of internal and external stakeholders including global internal functions, customers, and Health Authorities. In this role, you will be empowered to influence and improve processes and engage in matters that are important for the quality of our medicinal products. You will also get the opportunity to develop yourself professionally in an international environment.

Responsibilities will include e.g.:

  • Creation, development and maintenance of Quality Management System procedures and training materials pertaining to the Quality/GDP area
  • Handling of Product Quality Complaints, including e.g., internal reporting and responding to external customers
  • Handling of tasks related to deviations, CAPAs, recalls, destructions, returns, risk management, self-inspections and change control
  • Oversight of distributors and outsourced activities
  • Support in the completion of RPI checks
  • Support with the development and maintenance of the local Quality training program
  • Performing internal/external trainings of personnel 
  • Handling of batch-specific control for vaccines (batch commercialization)
  • Maintaining the subsidiaries in a state of inspection readiness
  • Support with management of audits and inspections of the local office

Qualifications:

  • Completion of a university or other higher education course of study in pharmacy, chemistry, biology, or a related life science is required
  • Experience from a Quality Assurance position in the pharmaceutical industry (at a minimum two years)
  • Strong leadership skills and ability to lead your own work
  • Good communication and organization skills
  • Strong computer skills
  • An understanding of the principles and guidelines of GDP, and personal knowledge of the relevant provisions of all relevant laws, regulations and provisions concerning medicinal products for human use
  • Experience using Veeva Vault & SAP (Comet)
  • Experience with batch commercialisation (NIBSC & MIFs)
  • Fluency in English
  • Ability to work in a team which spans across several countries

Our Quality Assurance group ensures that products are stored and distributed in accordance with our quality standards and meet applicable regulatory requirements.  Partnering across our internal manufacturing facilities and suppliers, we create an interdependent global network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/26/2024

*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.


Job Posting End Date:07/26/2024


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.


Requisition ID:R305421