QA/GMP Consultant

For one of our clients in the pharmaceutical industry, we are currently looking for a QA/GMP Consultant/QA Vendor

Start: 1/6/13
Length: 7 months
Location: South of Brussels

Job Description:

Be part of a proactive, solution oriented operational QA team that will drive quality activities for life cycle management of Strategic Partners and Vendors and the associate Products portfolio.
This position will support timely review and processing of Quality product complaints, deviations, and change controls, to support delivery of safe, efficient and compliant products to patients in partnership with key stakeholders.
In addition, the contractor will support the preparation, review process, and approval process of Quality Agreements with partners and contract manufacturers.
Administrative support to management of GMP documents will be part of this role.

Job responsibilities:

* Provide advice and support for technical Operational QA with a specific focus on:
- Reviewing investigations
- Reviewing specific deviation reports, complaint reports, changes and other risks that could impact product performance
- Perform reviews of GMP documents
- Administrative management of archiving of GMP documents

* Quality Agreements: support the drafting and signature of Quality Agreements from A to Z, in particular:
- Identify stakeholders
- Collect information and data
- Prepare draft Quality Agreement based upon pre-defined contract template using EDMS. Fill in all product and key contact data as wellas document properties and verify correctness with stakeholders
- Initiate and coordinate review of drafted Quality Agreement inside EDMS system Review and assess proposed comments and modifications
- Present final Quality Agreement version to management for final approval and signature process
- Track progression of Quality Agreement preparation and signature in tracking tool

* Product quality complaints: manage quality complaints from A to Z (reception and logging of complaints in tracking database, identify stakeholders, coordinate complaint review, provide final report)
* Change Controls: changes raised by CMO's and contractors; prepare background info for review; support the entire process (does not take the lead)
- Receive and log change controls in specific tracking data base/tool
- Prepare formal change control evaluation documents
- Follow-up with change requester (internal or external) to collect all information required to support effective change control evaluation
- Identify internal stakeholders and coordinate stakeholder assessments
- Present change control evaluation to QA Director Strategic Partnerships for follow-up discussion in Change Control Board
- Track change controls to be initiated and managed in electronic change control tracking system
- Participate as support in Change Control Boards

* Supportive Quality documents:
- Receive specific requests from external partners and customers for supportive Quality documents (eg, declarations, certificates)
- Identify internal or external stakeholders
- Request stakeholders to prepare and provide requested supportive Quality documents
- Perform Quality check of received supportive Quality documents
- Provide supportive Quality document to requesting external partner or customer
- Administrative support to archiving of GMP documents

* Assist Strategic Products and Vendors QA team with the resolution of issues relating to the release to the market of the product portfolio and work with the assigned technical team for the efficient release.
* Work in accordance with HSE and Corporate policy requirements
* Specific professional/technical expertise and key skills required:

1. Experience
* Minimum of 2 years working in the pharmaceutical/biologics industry. Quality management and operational GMP experiences would be a distinct advantage.
* Experience and knowledge about European Good Manufacturing Practices
* Basic knowledge about key Quality Systems in Pharmaceutical Industry, in particular Change Control, Product Complaints, Deviations
* International experience a plus

2. Specific skills
* Fluent and confident use of English language verbally and in writing
* Basic and practical knowledge and understanding of European
* Good Manufacturing Practices with respect to Change Control System, Product Quality Complaints, and Deviation Management
* Quick Learner to apply use of advanced IT solutions to manage documents and electronic workflows (eg, EDMS, TrackWise)
* Structured working approach with confident application of documentation practices in accordance with Good Manufacturing Practices
* Must have a good knowledge of pharmaceutical regulations together with quality principles and techniques
* Must be able to effectively interact with internal and external personnel on many aspects of product related matters. Be confident in providing constructive feedback (and accepting feedback) from work colleagues
* Must possess good interpersonal, verbal, and written communication skills and be able to confidently present information at interdepartmental and external meetings. Ensure free flow of information throughout the sphere of work.
* Contributes to the achievement of outstanding performance through teamwork.