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description de la société
For our client, a world leader in the pharmaceutical industry, we're looking for a contracted Medior/Senior Commissioning & Qualification Engineer (Subject Matter Expert) within the Engineering & Maintenance department for a period of 8 months (start July 1st)!
The Medior/Senior Commissioning & Qualification Engineer (Subject Matter Expert) will report to the C&Q Team Coordinator.
description de la fonction
Randstad’s mission is to shape the world of work by being a world leader in matching supply and demand in the labor market and in HR services. Randstad Professionals is part of the Randstad Group and creates opportunities for highly qualified and skilled professionals to work on successive projects on customers’ site.
The function holder:
• Is responsible to maintain the qualification status of systems in support of new, transferred and existing products through definition & maintenance of contemporary methodologies & standards. • Is responsible for review of System Qualification documents. • Act as Technical Owner within the JSC Beerse Organization • Act as Subject Matter Expert for Combination Products within the Qualification Engineering group • Steers under minimal guidance specialists and contractors within own discipline and/or responsibility area • Participates in the development of global standards/guidelines, reviews local standards/guidelines
- Participate in system and process change projects and assure quality and compliance aspects. - Participate in system and process introduction projects and assure quality and compliance aspects. - Identification and remediation of gaps in the qualification files of existing systems. - Act as a SME (Subject Matter Expert) for the Qualification Engineering impact assessment of the Change Controls. - Prepare for internal and external inspections. - Be the spokesperson and Subject Matter Expert during audits and inspections, as pertains Qualification Engineering topics. - Based on expertise, makes strong recommendations on investigations, investments or projects. - Internal & external networking
GENERAL ACTIVITIES QUALIFICATION ENGINEERING:
- Maintain a current knowledge of international regulations, guidelines and industry practices related to system (process equipment) qualification. - Generate and maintain the area Validation Master Plans, containing an inventory of all existing systems and their qualification status. - Report on a periodic basis the System Qualification status (incl VMP completion rate) in the different departments. - Perform periodic assessments (PSQR) of the overall quality of GMP critical systems and decide upon the need for re-qualification. - Writing and Review of User Requirement Specifications (URS) - Review of System Requirement Specifications (SRS) - Writing and Review to the Qualification Impact Assessment (IA). - Writing and Review of system qualification documents such as DQ/IQ/OQ - and PQ protocols/reports, QSR. - Responsible for writing and review of discrepancies occurring during execution of qualification activities. - Make sure that all deliverables out of qualification are implemented in the Q systems: Master Batch Records, SOPs, Work instructions, Calibration records, ... - Be the back-up Process Owner for Equipment Qualification management.
▪ 5+ year work experience in pharmaceutical industry ▪ Understanding of J&J and global related operating companies and supply chain environment ▪ Expertise in multiple disciplines and knowledge of company business
▪ Knowledge of GMP requirements, methodologies, concepts and requirements related to system validation ▪ FDA – 21 CFR Part 210, 211 Good Manufacturing Practice for Finished Pharmaceuticals ▪ FDA – 21 CFR Part 11 Electronic records and electronic signatures ▪ EudraLex, The Rules Governing Medicinal Products in the European Union Volume 4: EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use ▪ European and United States Pharmacopoeia and applicable guidelines. ▪ Is point of contact to customers for systems and processes within own field of expertise and makes the final technical decision for change
Personal and interpersonal skills:
▪ Project Leadership skills ▪ Ability to take decisions ▪ Ability to work under pressure ▪ Ability to handle conflicts ▪ Ability to work independently under general direction ▪ Team player ▪ Have good sense of priorities for assigned tasks / goals and manage time accordingly
▪ Willing to place the goals or the team first and work with others towards these goals ▪ Communicative / assertive person ▪ Motivator / Negotiator / Leader ▪ Showing a high sense of responsibility regarding professional activities ▪ Work with deadlines ▪ Takes care of safety, health and environmental and ethical behavior
Good Manufacturing Practices:
▪ Always use the appropriate cGMP’s and procedures ▪ Report incidents and deviations ▪ Propose solution to improve compliance with cGMP’s
Safety, Health and Environment Performance:
▪ Always use the appropriate prevention rules and procedures ▪ Correct use of the available personal and collective protection materials ▪ Work neat and tidy ▪ Reporting of (almost) accidents, incidents, deviations and risky situation ▪ Cooperate on and suggest solutions to improve safety, health and environment ▪ Participate actively on promotion campaigns, working on the “Safe behavior program, prevention controls… Address to employees and third parties when violation according to the safety procedures and unsafe behavior occurred
- University degree in Engineering or Science (or equivalent based on experience) - 3+ years of experience in Commissioning & Qualification of Pharmaceutical Manufacturing Equipment
Fluent in written and spoken English and Dutch
You are flexible and you will receive a lot in return. You will get an attractive salary package with extra benefits: - group insurance, - hospitalization, - meal vouchers, - trainings.
If you feel attracted by this challenge then please contact me: