Senior Quality Assurance Officer & Responsible Person at Basic Pharma
6160 Geleen, , Netherlands -
Full Time


Start Date

Immediate

Expiry Date

01 Jul, 25

Salary

0.0

Posted On

01 Apr, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

English, Software Systems, Quality Auditing, Pharmaceuticals, Communication Skills, Affinity

Industry

Pharmaceuticals

Description

OUR COMPANY

Interdos, part of the Basic Pharma Group, is based at the Brightlands Chemelot Campus in Geleen, the Netherlands. Basic Pharma, a unique Dutch pharmaceutical company, is rapidly expanding, continually strengthening its organizational foundation, and advancing its specialization within the pharmaceutical industry. From product development, registration, production, and commercialization of (bio)pharmaceutical products to providing pharmaceutical services, Basic Pharma serves a diverse clientele ranging from startups to multinational corporations, both nationally and internationally.
Basic Pharma Manufacturing, manufactures various products such as nasal sprays, filled syringes, creams, and ointments. It also offers study medications and diverse services to third parties, including quality control and contract manufacturing.
Basic Pharma Technologies focuses on developing pharmaceutical products collaboratively with partners for its production organization and out-licenses them to customers. This unit now operates a biotech facility dedicated to product development and study medications.
Interdos specializes in providing consultancy services in the Regulatory Affairs, Pharmacovigilance, and Quality Management fields. Our expertise extends not only to internal support for Basic Pharma but also to external partnerships, ensuring seamless compliance and quality standards across the pharmaceutical landscape.
The synergy of these activities under one roof positions Basic Pharma as a resilient and versatile player in the pharmaceutical industry. With approximately 200 professionals, Basic Pharma’s ambitions are expanding, prompting the search for individuals committed to professionalism and customer satisfaction. If this resonates with you, consider the following exciting opportunity.
Position Available at Interdos:
Senior Quality Assurance Officer & Responsible Person

REQUIREMENTS FOR A SENIOR QUALITY ASSURANCE OFFICER & RESPONSIBLE PERSON?

  • At least HBO-level education and thinking.
  • Minimum of 5 years of relevant work experience, preferably in a GMP and/or GDP environment.
  • Accurate, stress-resistant, eager to learn, strong communication skills, and adept at collaborating with diverse disciplines.
  • Persuasive with analytical abilities.
  • Proficiency in English (spoken and written).
  • Affinity with software systems.
  • Quality Control and Quality Assurance skills.
  • Analytical Skills and Quality Management experience.
  • Experience with Quality Auditing.
  • Excellent attention to detail and organizational skills.
  • Ability to work independently as well as part of a team.
  • Strong understanding of pharmaceutical regulations and compliance standards.
  • Relevant degree in Quality Management, Pharmaceuticals, or related field.
Responsibilities
  • Coordinate the implementation and maintenance of various quality management systems (primarily GMP/GDP, partially ISO 13485/MDR).
  • Facilitate the implementation of new quality regulations (GMP/GDP/MDR).
  • Ensure compliance with training activities.
  • Conduct (internal and external) GMP/GDP audits and oversee follow-up actions.
  • Provide training to employees and management (GDP/GMP).
  • Assist in the development of work processes, ensuring effectiveness and efficiency.
  • Guide and support the documentation of the above activities for completeness and traceability of documented evidence.
  • Contribute to the Management Review.
  • Support supplier qualification.
  • Review and draft Product Quality Reviews.
  • Assist in GMP and GDP audits and inspections by government authorities and clients.
  • Assist partners in applying for wholesaler- and manufacturer licenses.
  • Responsible for tracking and reporting quality complaints, deviations, changes, and CAPAs.
  • Increase professionalism within the QA departmen
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