Quality Assurance GMP - Expert 3415

12-7-2019 braine-l'alleud
company profile

Our client
is a global biopharmaceutical company focusing on creating value for people
living with neurology and immunology conditions.


job description

Do you have minimum 5 years experience working in the pharmaceutical/biologics industry in a quality management position? Then you are the person we are looking for!

Support to Product QA Stewardship & Strategy:

  • Ad hoc member of TST. Participation as requested
  • Provide QA support for commercial initiatives (projects) as requested
  • Support maintenance of detailed QA Product Flow Overview globally for assigned products
  • QA stakeholder for Product Risk management
  • Identify quality improvement needs for the assigned products and liaise with key stakeholders and management accordingly
  • Monitor key performance indicators (metrics) for key product QA activities and services associated
  • Provide support for regulatory inspections. Ensure and facilitate regulatory inspections related to the accountable products are well prepared and key stakeholders are available for support during the inspections. Support post inspection observation closure

Support to Commercial Product QA Operational Accountabilities:

  • Provide QA support for commercial activities as requested
  • Deputise as a Lead of Global Products Change Control Committee(s) as requested
  • Deputise as a Lead of Global Products Customer Complaints Committee(s) as requested

Periodic aggregation and trend analysis of product complaints; identification and implementation of CAPA

  • Oversee Annual Product Quality Reviews for accountable products. Review and approve Executive PQR Summary Reports for accountable products
  • Review and approve Product Stability Strategy for accountable products (for products where applicable)
  • Reviewer and approver of Specification for the accountable products in the case of external QP (for products where applicable)
  • QA reviewer and approver for all global Methods associated with the accountable products in the case of external QP (for products where applicable)
  • Maintain a Product Collaboration Site with Product QA Cockpit for the Products
  • Maintain a QA Cockpit for the Products (Quality Agreements, PQRs, audits, manufacturing chain and vendors, complaints, certificates, product contacts, change controls, recalls, launches,…)

Support to Development Quality Pharma Sciences Accountabilities:

  • Ensure the QA project support of the CMC process development and clinical supply including analytical work, manufacturing, review and release, technology transfer, CMC filing,… from early phase to commercial launch of the product.
  • Support the activities of CMC and Development QA Pharma Sciences for relevant quality systems (deviation close out / Change management/ complaints / quality improvement)
  • Ensure adequate documentation processes and systems are available and followed for CMC development projects (SOPs / Protocols review /approval)
  • Write Quality Assurance Agreement between CMO and  Development Quality PharmaSciences 

General accountabilities:

  • 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 Global Quality Leads when requested


your contribution

Minimum of 5-8 years working in the pharmaceutical/biologics industry in a quality management position. 

Good knowledge and understanding of Good Manufacturing Practices (GMP) Regulations and CMC Regulatory requirements 

English : Advance level - which is the main day-to-day language required for this position. French language skills is an advantage 

Must be able to act in most circumstances without direct supervision and handle complex situations. 

Auditing expertise would be an distinct advantage


what do we offer?

We offer an attractive salary with extra-legal advantages : 

- Group insurance

- Hospitalisation insurance

- Meal vouchers of 7 euros gross per working day

- Reimbursement km or company car 

- Monthly allowance (50 euros net per month)

- A 13th month

- Training

- Etc.

A rate as freelance is also possible.


summary
function
quality and environment specialist (m/f)
employment type
full time, freelance
contract type
immediate permanent employments
reference
CXRSP-83609
your Randstad contact
Pieter Gurny
pieter.gurny@cx.ausy.be