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Validation Registration Engineer

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Sophie Steels
Career Manager


Postulez ici

Sophie Steels
Career Manager



Sophie Steels
Career Manager


Description de l'emploi

QPA QO Launch Excellence
This project is accountable to ensure:
-Regulatory CMC (= Chemistry, Manufacturing & Controls) compliance of the plant processes with the regulatory filings
-Product Quality as the independent quality authority for product-related qualifications and validations of the assigned products.
- Compliant and right first time product launches within Quality Operations (QO) oversight

ORGANIZATIONAL RELATIONSHIPS
This position is assigned one or more specific product(s) for which he/she is responsible.
This position reports to the Team Lead QO Launch Excellence Validation/ Launch.

The incumbent has daily interdepartmental contacts in the site and interaction with Global Pfizer bodies (eg.GCMC (=Global Chemistry, Manufacturing & Controls), R&D).

EXPERIENCE
Master Degree - Scientific discipline (eg. Pharmacy, Biomedical Sciences, Bio-engineer, …)

Ideally the consultant has 2 years of relevant experience in the pharmaceutical sector and/or medical device industry (or equivalent by acquiring a PhD) with specific experience or interest in Quality Assurance or Compliance and in regulatory affairs (CMC) for (Bio-)Pharmaceutical products.

- Quality mindset
- Pragmatic
- Excellent analytical and problem solving skills
- Excellent oral and written communication skills and social skills
- Scientific knowledge and skills
- Languages: fluent in Dutch and English
- Excellent knowledge of cGMP, regulatory guidances and relevant medical device and combination product regulations.

PRINCIPAL Scope of work:
This project is part of the QO Launch Excellence department, which is the independent product-oriented quality organization that has certain responsibilities concerning validation, registration and implementation within the site. Each QPA is assigned one or more specific Launch Excellence product(s) for which he/she is responsible.


Registration
The composition, production processes, specifications, analytical methods of the drug products are described in the registration dossiers of the different markets. The QPA is responsible to pursue regulatory CMC compliance of the site practice versus the registration dossiers. This is achieved by participating in the following processes:

- Data verification and QA review of initial marketing authorization filings and variations, responses to health authority queries, briefing documents for scientific advice meetings
- Performing compliance checks of the registration dossiers of the different markets versus the site practice
- Regulatory change control process: Coordinate regulatory impact assessment for proposed product-related changes

Validation
Act as quality authority in a consistent way, in compliance with cGMPs and current regulatory expectations, for the following qualification and validation documents:
- Process qualification/validation
- Method validation
- Filter validation
- Component qualification
- Raw material evaluation


Implementation
Ensure correct and timely implementation of approved regulatory changes in the site: follow-up on approvals and commitments in the different markets, and work with the technicians to update and/or launch the systems (RSS process, LIMS system, SAP, MBR, BRM etc).

Ownership of launch coordinator role within Quality Operations (QO) oversight, for Launch Excellence product(s) for which he/she is responsible.

Depending on the individual situation, the Quality Project Associate is accountable for:

Ownership of quality systems and SOPs (eg. Regulatory Filing Management), to ensure the process is efficient, effective and compliant.

  1. Design the process and define roles and responsibilities
  1. Act as a quality system contact person during regulatory inspections
  1. Managing routine and complex continuous improvement projects and corrective and preventive actions for these quality systems
  1. Knowledge management of requirements, best practices and interdepartmental alignment

Profil

  • Master Degree - Scientific discipline (eg. Pharmacy, Biomedical Sciences, Bio-engineer, …)
  • relevant experience in the pharmaceutical sector and/or medical device industry (or equivalent by acquiring a PhD) with specific experience or interest in Quality Assurance or Compliance and in regulatory affairs (CMC) for (Bio-)Pharmaceutical products.
  • Quality mindset
  • Pragmatic
  • Excellent analytical and problem solving skills
  • Excellent oral and written communication skills and social skills
  • Scientific knowledge and skills
  • Languages: fluent in Dutch and English
  • Excellent knowledge of cGMP, regulatory guidances and relevant medical device and combination product regulations.


Postes vacants connexes

Quality Specialist Operations - shiften


Project Lead Packaging


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Coordonnées de contact

Formation et expérience

Nombre d'années d'expérience*

Postes vacants connexes

Quality Specialist Operations - shiften


Project Lead Packaging


+32 16 309 509