Global Quality Systems Manager
hace 5 días
About Us
\Centrient Pharmaceuticals is a leading manufacturer of beta-lactam antibiotics and a provider of next-generation statins and anti-fungals. The company produces and sells 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 are committed to a sustainable future by actively participating in the fight against antimicrobial resistance.
\Job Description
\The QMS Manager will define/revise and implement a clear and robust document hierarchy for global documents. Put in place an integrated documentation structure that 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.
\Main 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:
\- \
- 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.\
Estimated Salary Range: $120,000 - $150,000 per year based on location and experience.
\About Our Company Culture:
\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, giving you a lot of freedom and responsibility in an open, direct, and informal atmosphere.
\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.
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