Quality Systems Specialist

Job Description

For our Biotech organization in Oss , we are looking for a:

Quality Systems Specialist

Welcome in our team!

Quality Operations Biotech (around 100 people) is responsible for ensuring that our Manufacturing Division manufactures, tests and releases Biological Drug Substances and Bulk Drug Products in accordance to applicable local and international regulations. To this end the various Quality departments actively collaborate and set standards for all other Integrated Process Teams (IPTs) and CoEs (Center of Excellences) of our Manufacturing Division Oss as well as regularly interact with other Manufacturing Division sites.

This position is for the Quality Systems team within the Quality Operations organization.

Purpose of the role

The Quality Systems specialist main responsibility consists of preparation, execution, reporting and follow-up of internal site process and system audits and walkthrough audits. Other responsibilities are the preparation, execution and follow-up for external audits and inspections and maintaining Health Authority relevant documents, like the Manufacturing license and Site Master File.

Main tasks

• Supporting all internal verification and system/process audit activities which are in line with relevant quality procedures, guidelines, and directives to ensure Permanent Inspection Readiness and to monitor the status of GMP level, status and action steps or other relevant performance indicators.
• Providing advice/guidance to the functional areas on quality knowledge, procedures, guidelines, and directives.
• Execution of all necessary means regarding preparations, execution, and follow-up on inspections at our company.
• Execution of all necessary means regarding Inspection relevant documents (Manufacturing License, GMP Certificate, Site Master File, Authority Accreditations).
• Providing day to day support, raising concerns if needed or directing users to do so. Partner with relevant internal and global groups (e.g. FDA, EMEA) for building, maintaining and sharing knowledge and information.
• Active contribution to realization of corporate policy on safety, health, and environment. Demonstrate personal commitment with respect to working safely, healthy and environmentally friendly.

Your profile

• At minimum a bachelor’s degree (Dutch: HBO/ HLO), preferable in science or comparable work experience.
• At least 5 years of relevant experience in the pharmaceutical industry and cGMP.
• Applied knowledge of relevant Quality and Compliance Guidelines (cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, Training), and respective regulations.
• A flawless quality mindset and able to convert this mindset into practice and with strong leadership skills to bring others on the same page.
• Computer literacy knowledge
• Excellent interpersonal and communication skills, verbally and written (Dutch and English).
• Ability to work independently as well as in teams.
• Effective planning and structured working skills.
• Strong focus on clients and end-user

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 trainings, 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/31/2024

*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: 08/31/2024

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: R306739