C&Q Subject Matter Expert
C&Q Subject Matter Expert
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Job Description
- Provide technical direction and leadership to ensure appropriate C&Q activities are performed in line with clients requirements.
- Offer technical governance to the project delivery organisation throughout the project lifecycle.
- Champion the overall Operational Lifecycle within specialist areas including pharma industry C&Q good practices facilities and utilities process equipment and GAMP approach for OT systems.
- Lead C&Q engineer and contractor training as required.
- Ensure key GMP compliance requirements are reflected in C&Q deliverables and review GMP Compliance Tracker topics.
- Engage with clients key stakeholders to understand and reflect their needs in C&Q activities.
- Develop C&Q protocols in collaboration with C&Q Contractor and Engineers translating clients needs into C&Q requirements.
- Provide technical approval and support for commissioning and qualification activities including review and approval of FATs SATs DQ IQ and OQ protocols for GMP and critical GEP systems.
- Offer technical best-practice advice to work package teams and provide tactical direction to resolve technical difficulties during C&Q execution.
- Support lessons learnt for technical work packages and C&Q management.
Qualifications :
- Bachelors or Masters degree in Engineering Life Sciences or related field; advanced degrees or certifications in Quality Management Regulatory Affairs or Pharmaceutical Sciences preferred.
- Extensive experience in C&Q activities within the pharmaceutical industry with a proven track record in managing GMP compliance and quality assurance.
- In-depth knowledge of GMP GEP and GAMP guidelines with proficiency in developing and reviewing C&Q protocols (FATs SATs DQ IQ OQ).
- Demonstrated ability to lead and train C&Q engineers and contractors providing technical governance throughout project lifecycles.
- Excellent communication skills to engage with key stakeholders and translate client needs into actionable C&Q requirements.
- Strong problem-solving skills and commitment to continuous improvement initiatives.
Additional Information :
Our inspired people share our vision and mission. We provide a great place to work where each person has the opportunity and voice to affect change.
We want our people to succeed both in work and life. To support this we promote a healthy productive and flexible working environment that respects work-life balance.
Turner & Townsend is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees and actively encourage applications from all sectors of the community.
Please find out more about us at our social media conversations for more information about Turner & Townsend and our exciting future projects:
It is strictly against Turner & Townsend policy for candidates to pay any fee in relation to our recruitment process. No recruitment agency working with Turner & Townsend will ask candidates to pay a fee at any time.
Any unsolicited resumes/CVs submitted through our website or to Turner & Townsend personal e-mail accounts are considered property of Turner & Townsend and are not subject to payment of agency fees. In order to be an authorised Recruitment Agency/Search Firm for Turner & Townsend there must be a formal written agreement in place and the agency must be invited by the Recruitment Team to submit candidates for review.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
