Position: CQV / Validation Lead
Job Description
We are currently expanding our team and are looking for a CQV / Validation Lead for our project on site with our client.
You will be responsible for overseeing, planning, writing, implementing and reviewing Validation protocols in place within highly regulated environments. Your expertise will lend a hand in tactical problem-solving, effective communication, and creating a progressive growth culture.
Key Responsibilities:
- Reporting to the C&Q Manager.
- Abide by all safety requirements and procedures pertaining to their role; serve as a positive model to others in this regard; re-enforce 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 it’s implementation in execution.
Requirements:
- Strong driver for timely execution and close out of C&Q protocols.
- Issues resolved in reasonable time before they impact critical path of Project.
- Issues identified, discussed, closed out and documented clearly.
- Proficient in the use of Kneat for C&Q document preparation and execution.
What’s in it for you?
- Exposure to the most renowned Pharmaceutical companies in the industry
- Annual leave benefits
- Full Medical coverage
- Training and Development allowance
If you are interested in applying for this position, please send an email to [email protected].
Coalesce Management Consulting operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.
