Project Manager, Commissioning & Validation R&D
- Master in Pharmacy with complementary master in Industrial Pharmacy
- >5 years of experience in Pharmaceutical Industry
- 5 years of experience in commissioning and validation of equipment and Utilities systems ( GMP and non GMP)
- Fluent in English
- Good communication skills (presentation, leading workshops, SOP trainer..)
Manage the alignment of Commissioning/Validation/requalification process in all activities of R&D sites : Belgium, Rockville (US), Sienna (I) and Marburg (G), concerning equipment and facilities ( Out of scope :IT integration and Computer System Validation)
- Define in a Master SOP about the governance of validation / commissioning/requalification for equipment and facilities.
- Support the implementation of the requirement defined in the Master SOP of Commissioning –validation-requalification
- Support the implementation of the process for the Pre-approval –approval of Commissioning/validation/ Requalification required protocols
- Owner of the Master SOP concerning the Commissioning – validation and requalification of equipment and facilities through the different R&D sites (Belgium, Rockville (US), Sienna (I), Marburg (G) according to the QA expectations
- Write the global master SOP with QA support
- Assess the validation process in place and suggest the alignment through the sites (process, protocols, organization)
- Give the training on the different site
- Update and review the SOP according to the business needs
- Support the working group for the implementation of the local SOP of Commissioning/Validation/ requalification process .
- Transversal support for Commissioning and validation of Equipment – Validation-Requalification:
- Expert of process validation for each site
- Establish C&Q International R&D network and C&Q International Committee
- Lead the C&Q Committee
- Support the implementation of the local SOP according to the organization in place and QA expectation.
- Continuous Improvement of the transversal C&Q process (risk analysis, new guideline, QA expectation…)
- Support the implementation of the process, pre-approval/approval of Commissioning-validation & requalification protocols in the different site according to the different organization and QA expectation.
- Support the Implementation of a transversal electronic system for review –pre-approval and approval protocols documents (Techshare, files services…)
- Key contact for Commissioning –Validation and requalification support
- Support the harmonization and Write template of documentation (VP-CER-IQOQ….)
- Follow up of the Commissioning-Validation Activities :
- Organize audit L1 on the different site to check up GSOP applicability
- Organize international meetings.
- Travelling :
- Minimum 1 time / month
- Management :
- Minimum 1 or 2 people of the team
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
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