C&Q PROCESS LEAD
Descrizione dell'offerta di lavoro
You will be working with our client who are a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.
This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.
Responsibilities.
Accountable for the team drafting or support the document drafting by a partner or supplier, coordinate review and approval of applicable C&Q documents (QRA/DV/RTM/FAT/SAT/IOV/VSR) following approved VMP and SLIA.
Drive verification testing, protocol execution, walk-downs, verification of system drawings, design and operational testing and troubleshoot as required.
Conduct deviation investigation and resolution for problems and issues encountered during field execution activities.
Act as C&Q Subject Matter Expert and Compliance.
Ability to provide guidance/ manage supplier and all C&Q activities for the system(s), from design to field execution and to summary report approval.
Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s).
Take appropriate corrective actions as required to ensure deadlines and milestones are achieved.
Accountable for the Review and acceptance by the team of turnover of equipment / system from construction group.
Ensures Start-up of equipment/ system is completed in a safe and coordinated manner.
Generate and or review change controls related to C&Q and drive their closure in a timely manner Ensures all personnel who perform C&Q activities for the system(s) have relevant training assigned.
Assist/ facilitate in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Systems in scope.
Requirements.
Requires extensive, hands-on, end to end experience with this equipment in International CAPEX C&Q.
Technical qualification at third level or equivalent in Engineering.
English is must.
Extensive knowledge and demonstrated experience delivering Commissioning and Qualification for Pharmaceutical / Biotechnology projects including automation related aspects of equipment.
Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry.
Experience with ISPE best practice / GAMP-5/ Anex 15 GMP EU/ ASTM E/ electronic execution.
Experience with Post OQ activities is preferred.
Experience of sterile / biotech / single use equipment in the bio-pharmaceutical industry is preferred.
Knowledge of safety, GMP and environmental regulatory requirements.
Ability to make decision under pressure and demonstrated strong Analytical/ Communication/ Leadership skills.
Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
If this role is of interest to you, please apply now! #LI-CB1
Dettagli dell'offerta
- Imprecisato
- Tutta l'Italia
- Imprecisato - Imprecisato
- 30/07/2025
- 21/02/2026
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