Global Quality Documentation Specialist
hace 3 semanas
At Centrient Pharmaceuticals Netherlands, we are a leading manufacturer of beta-lactam antibiotics and provider of next-generation statins and anti-fungals.
We produce and sell intermediates, active pharmaceutical ingredients, and finished dosage forms.
We strive to be at the centre of modern healthcare as a maker of essential and life-saving medicines.
Our commitment to Quality, Reliability, and Sustainability drives everything we do.
We have over 2200 employees working tirelessly to meet our customers' needs and contribute to a sustainable future by participating in the fight against antimicrobial resistance.
Established 150 years ago, our company has its roots in the 'Nederlandsche Gist- en Spiritusfabriek', known as Gist Brocades.
Headquartered in Rotterdam, we have production facilities and sales offices in China, India, Spain, the United States, and Mexico.
The Global Quality team is seeking an experienced professional for the position of QMS Manager.
The successful candidate will define, revise, and implement a clear document hierarchy for global documents, ensuring they are easily accessible, secure, and standardized.
Key responsibilities include:
- Designing and implementing a robust document hierarchy aligned with current regulatory expectations.
- Drafting global quality procedures that adhere to evolving GMP and regulatory requirements.
- Standardizing, harmonizing, and revising the Quality manual and other GxP documents as needed.
- Ensuring procedures remain current and suitable for changing regulatory landscapes.
- Leading timely revisions and updates of global documents.
- Supporting the development and continuous improvement of Centrient Quality Systems.
- Providing leadership support during regulatory inspections and customer audits.
- Fostering effective training on global procedures across Centrient sites.
- Overseeing GxP quality audits and contributing to the corporate annual audit plan.
To excel in this role, candidates should possess:
- A Bachelor's or postgraduate degree in Science, Pharmacy, or a related field.
- A minimum of 8-10 years of industry experience.
- Advanced English language proficiency (written and spoken).
- In-depth knowledge of cGMP and regulatory requirements.
- Proven technical writing skills.
- Prior experience in similar roles with strong organizational skills.
- International exposure and ability to manage cultural differences.
- Excellent communication and interpersonal skills.
Estimated salary: €80,000 - €110,000 per annum, depending on experience and qualifications.
Join us in a challenging and comprehensive operational environment with opportunities for growth and personal input.
This role offers a local contract, flat organization structure, and open atmosphere with plenty of discussions with professionals.
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