QMS Manager

Description

Centrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms.

We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines.

With our commitment to Quality, Reliability and Sustainability at the heart of everything we do, our over 2200 employees work continuously to meet our customers’ needs. We work towards a sustainable future by actively participating in the fight against antimicrobial resistance.

Founded 150 years ago as the ‘Nederlandsche Gist- en Spiritusfabriek’, our company was known as Gist Brocades. Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, the United States and Mexico.

The Global Quality team has a vacancy in its team for the following position:

QMS Manager

The QMS Manager will define/revise and implement a clear and robust document hierarchy for global documents. Put in place an integrated documentation structure which is simple, effective, secure and easily accessible. Standardize and harmonize global quality procedures and policies within the global quality organization. Support training and implementation of these procedures.

The main activities and responsibilities

• Define and implement a clear document hierarchy for global procedures and policies.
• Design and (re-)draft global quality procedures that are aligned to the current regulatory expectations.
• Revise or revisit Quality manual and other GxP documents, standardize, harmonize and/or simplify as required.
• Ensure that the procedures are current and suited to evolving GMP and regulatory requirements.
• Timely revision and updating of global documents.
• Support development & continuous improvement of Centrient Quality Systems.
• Support leadership teams in regulatory inspections and customer audits.
• Support effective training of global procedures across Centrient Sites.
• Lead and/or support GxP quality audits and monitor corporate annual audit plan.

Requirements

The Ideal Candidate

• Bachelor or post graduate degree in Science, Pharmacy or related field of study.
• +8 - 10 years of industry experience.
• Advanced level of English language (written and spoken).
• In depth knowledge of cGMP and regulatory requirements.
• Proven skills in technical writing.
• Prior experience in similar roles with good organization skills.
• International exposure and ability to manage cultural differences.
• Ability to obtain commitment on required actions.
• Resourceful in finding and keeping abreast of the latest developments in the cGMP and regulatory environment.

Benefits

Terms and reward

We offer a local contract in a challenging, comprehensive, operational environment, with many opportunities for personal input and growth and plenty of discussions with other professionals. The organization is very flat. You have a lot of freedom and responsibility in an open, direct, and informal atmosphere.

The Procedure

Please submit your application via the 'apply' button and upload your CV & cover letter in English. We also ask you to include information on your current remuneration. Only applications with CV and Cover Letter will be considered.

For more detailed information about the role and about the Recruitment & Selection process you can contact us via HRSpain@centrient.com. We invite you to visit our website www.centrient.com for information about our company.

Reference check procedures are part of the Centrient Recruitment & Selection Process. You will be contacted when a reference check is required.