Quality Vendor Manager Product Supply QA-BRA00002992 Job in Walloon Brabant-Braine-l'Alleud, Belgium

UCB is a global biopharmaceutical company, with a focus on neurology and immunology.

Our business is strong. Total revenue grew to €4.2 billion in 2016. We are more than 7,700 people in all four corners of the globe, inspired by patients and driven by science.

Looking ahead, we have a solid platform for continuous growth with our core products Cimzia, Vimpat, Neupro, Keppra and Briviact, and we are preparing the launch of a potential medicine to help patients with osteoporosis. At the same time, we are very excited about the progress in our early research pipeline.

Quality Vendor Manager Product Supply QA-BRA00002992 Job Description

Key responsibilities

• Covers the entire product life cycle from initial commercialisation including Technolgy Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out at a specified Vendor
• Support vendor assessment and selection activities (e.g. QA questionnaire , quality agreement and on site audit)
• Support vendor renewal and phase out activities (e.g. stability, archiving of GMP document, retain samples, etc…)
• Align and coordinate launch QA requirements with the vendors
• Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders, Regulatory Affairs and Affiliates in an effective and efficient way
• UCB operational QA link between vendors & UCB for the commercial products
• Responsible for the routine LifeCycle Product Management activities at the assigned Vendor
• Act as a back up to the PQL as identified
• Provide expert QA advice, support and management for technical operational QA and general QA matters for the supply chain for the product. Specifically focus on the following:

1. UCB operational QA link between vendors & UCB for the commercial products at this Vendor .  Support  quality improvement initiatives and activities at vendors and UCB systems . 
2. Support projects associated with the product at this Vendor . 
3. Monitoring quality attributes to improve vendor performance . 
4. Develop and negotiate Quality improvement plans at Vendor site as necessary. 

1. Negotiation and setting QA agreements with Vendor .
2. Update the quality agreement when needed .
3. Vendor specific input into commercial agreement

1. Support Change management and ensure trending of types of changes at the Vendor, CAPA assessment, Tracking implementation and closure related to the Vendor and associated products

1. Facilitating/assessing/reviewing and ensure closure of investigations (incl. Deviation, Complaints, and OOS) at vendors .
2. GMP Doc .
3. Batch record review including review of CoA and CoC (if internal  UCB QP release) 
4. Creation and maintenance of deviation list .
5. Prepare documentation package for QP batch release  .
6. Perform review and approval of relevant GMP documents .
7. Collect and file cGMP certificates (for QA purpose only) .
8. Ensure reviews of GMP docs are completed (product specifications and methods, shipping qualification, etc...)  

1. Ensure distribution and updating of the list for methods & specifications to the Vendor .
2. Ensure routine stability program related to the product manufactured at the vendor . If applicable review and approve stability protocol and report of stability studies performed at the vendor 

1. Perform periodic audit for compliance with regulatory file per vendor:process

1. PQR/APR vendor review .
2. Review product SPCs and trends for batches with the vendor

1. Lead identification and mitigation of Vendor QA related risks   ·        
2. Product Disposition  

1. Regulatory support

1. Communications

• Work closely with staff in the Corporate QA teams and key Technical 
  Operations teams/Affiliate teams to ensure that all QA services for the Product are provided in an effective and efficient way.
• Establish key performance indicators (metrics) for key operational QA activities and services associated with the Product vendor supply chain and projects.
• As required provide Operational QA support to Vendors outside of the Product portfolio.
• Work in accordance with UCB HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
• Deputise for the Head of product supply when requested.
• Project Management

Quality Vendor Manager Product Supply QA-BRA00002992 Job Requirements

Qualifications

• Minimum of 10 years working in the Pharmaceutical Industry in a quality management position. operational GMP experience would be a distinct advantage.
• Experience interacting with regulatory bodies with respect to QA systems and regulatory inspection preparedness.
• Auditing experience.
• Experience with API and various dosage forms is an advantage.

Quality Vendor Manager Product Supply QA-BRA00002992 Application Information

Please apply with your CV and cover letter by the 'apply' button below.

Please use "Qreer.com" as reference in your application.

Quality Vendor Manager Product Supply QA-BRA00002992 Summary

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