C&Q lead

5 days ago

Singapore Unison Group Full time

Key Responsibilities Abide by all safety requirements and procedures pertaining to their role; serve as a positive model to others in this regard; re‐reinforce in meetings, perform periodic field observation and feedback as needed Lead a team as the system owner in preparing and executing Biopharmaceutical Process Equipment C&Q documents, ensuring achievement of the project schedule, track and report progress to the C&Q Manager Provide a strong working technical knowledge of Biopharmaceutical Process Equipment systems regarding the development of protocols, their execution, and close out Provide technical oversight to a Biopharmaceutical Process Equipment C&Q team to assure technical work quality, consistency, and alignment with the C&Q programme Work in the Kneat platform for preparation, review and approval of C&Q documentation with a key focus on traceability to User Requirements throughout Coordinate with the Engineering Compliance team, the QA team and other stakeholders in assuring all decisions on the document preparation for Biopharmaceutical Process Equipment systems are aligned and agreed Work collaboratively with the other project disciplines (e.g. automation, construction, engineering, end user) to support integration of activities. Train Biopharmaceutical Process Equipment personnel on the C&Q programme and its implementation in execution Report on any proposals for deviating from the C&Q program during doc development and execution to ensure they are addressed and, if agreed on, documented in a timely manner. Report issues for escalation where agreed document review and approval (pre and post, where applicable) turnaround times are not being adhered to Report issues for escalation where agreed execution timelines are not being adhered to Report any other issues which need to be escalated when no resolution is clear with the stakeholders internally Qualifications and Requirements 8 years minimum C&Q execution experience in the pharmaceutical sector with a minimum of 1 in a C&Q execution leadership role. Degree in engineering (M. Sc. / B. Sc.) or equivalent Demonstrated leadership and people management skills. Knowledge of GMP's, regulatory requirements, equipment commissioning and qualification. Ability to work well in a team environment. Able to manage multiple parties and coordination. Proficient in the use of DeltaV. Proficient in the use of Kneat. Travel: None #J-18808-Ljbffr

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