Associate Specialist Quality

Job Description

Do you want to work at one of the largest industrial pharma concerns in the Netherlands within a high-tech environment and use your knowledge and skills?  Did you always want to work in a company where your work can have a real impact on people’s lives? We would like to meet you!

We have an exciting new job opportunity at our location in Oss and are looking to hire a

Associate Specialist Quality

Purpose of the role
As Associate Specialist Quality you are a quality advisor for investigators and you recommend actions to ensure a state of continued compliance avoiding recurrence. You work with other departments providing guidance in product related GMP questions. Reviewing and approving cGMP documents associated to the product in compliance with site SOPs, Company Guidelines/ Procedures and federal as well as local agencies regulation supporting business goals is part of your job.

Welcome in our team

The department is called Quality Operations (QO) it has the following three sub-functions: Quality Compliance, Quality IPT and Quality Control. The Quality Department must ensure adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of our Manufacturing Division products according to our Manufacturing Division Policies, Guidelines, Procedures and regulatory requirements by appropriate oversight and monitoring.

Main responsibilities
Your main tasks will be, but not limited to:

• Serves as a quality advisor for investigators and recommends actions to ensure a state of continued compliance avoiding recurrence.
• Works with the IPTs/CoE providing guidance in product related GMP questions.
• Reviews and approves cGMP documents associated to the product in compliance with site SOPs, Company Guidelines/ Procedures and federal as well as local agencies regulation supporting business goals.
• As part of Quality on the Floor:
• Executes batch records review including correlating actions in other systems (PAS-X, SAP etc.)
• Performs Usage Decision on IPT manufactured materials (such as buffers, media, sterile assemblies, column pack)
• Reviews and approves logbooks and log sheets
• Reviews and approves cleaning and sterilization records
• Prepares documentation package for release for products manufactured at site
• Supports and approves investigations and CAPA plans assuring they are complete, accurate, technically justified with the required documented evidence
• Ensures quality concerns and/or opportunities are presented to management and/or project teams for prompt resolution.
• Manages, evaluates and approves changes assuring they are in compliance with applicable SOP’s, quality manual, products market filing, and qualification (as applicable) and are closed with all the supporting documentation.
• Participate in Quality Area projects to develop and implement improved/lean processes.

Your profile

• Bachelor’s degree (HLO) preferable in Biotechnology, Chemistry, with 2 years of relevant experience in the pharmaceutical industry.
• Experience with quality and compliance guidelines and manufacturing processes

• Knowledge of industry guidance and respective regulations of multiple areas like Production, Validation, Qualification, Quality Assurance, Quality Control, Quality (Management) Systems, Regulatory Affairs, Quality Agreements, Documentation, Inspection and Auditing.
• Technical writing, Root Cause Analysis, Failure Mode & Effect Analysis (FMEA), CAPA establishment and Lean Six Sigma.
• Quality by Design, Process Analytical Technology, product Qualification/Validation
• Excellent interpersonal and communication skills, oral and written (Dutch and English)
• Experience with documentation system and SAP preferable
  

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary and a 3% year-end allowance.
• 35,5 days of leave.
• Attractive collective health care insurance package with considerable reduction rates.
• Solid Pension Plan.
• Annual bonus based on own and company performance.
• Travel allowance for commuting.
• Numerous training, coaching and e-learning modules for long term job opportunities and development.

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:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID: R283992