External Quality Assurance Product Quality Manager

il y a 1 semaine

HeistopdenBerg, Belgique Organon Temps plein

Organon is a Women’s Health Company that believes in a better and healthier every day for every woman We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.

It’s going to be an exciting future—come be a part of it

Exciting position is now available for an **External Quality Specialist** to act as Product Quality Manager (PQM) responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with expectations and all applicable regulatory requirements.

This role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the External Partners EP/ExP’s manufacture and release of (API intermediates, API, non‐sterile pharmaceuticals, sterile pharmaceuticals, medical devices) by means of risk‐based quality oversight and on‐site supervision, as appropriate.

PQM will support partner relationships with activities of increasing complexity, scope, and volume which can be influenced by one or more of the following: number of products manufactured, number of partners supported, production volumes, number and complexity of in-markets, historical performance (production and compliance), new product or market launches, historical relationship between Merck and the partner, manufacturing process complexity.

**What you will do**:
Bring energy, knowledge, innovation and leadership to carry out the following:

- Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures of our company and compliance with all governing regulations; review and approve changes to master batch records
- Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer
- Provide support for audits of EP/ExP by our company and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted
- Oversee repackaging activities in the ExP/EP
- Conduct routine analytical change requests and support process modification change controls
- Stability Program management, including review of stability reports, and Annual Product Review assembly
- Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements
- Track and monitor operational and quality performance of the external manufacturer/partner
- Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine
- Support routine process validation; review and approve validation reports/tech transfer
- Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes
- Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums

**What skills you will need**:
In order to excel in this role, you will more than likely have:

- Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).
- Previous experience in the pharmaceutical industry with some knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred
- Ability to solve a range of straight forward problems with moderate level of guidance and direction
- Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals
- Responds to non-standard requests from clients and/or customers; investigations with assistance from others as needed
- Explains difficult issues and works to build alignment around a complex situation.
- Accountable for a medium project with mínimal

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