At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists.
Position: Document Controller
Job Description:
We are currently expanding our team and are looking for a document controller on site with a client. In summary, you will be supporting the GMP documentation of electronic repositories of a CAPEX project, and to ensure that tasks are performed according to requirements with review/verification of results and problem solving for issues identified.
Key Responsibilities:
- Media Transfer of documentation from contractor document control platform to the site's GMP documentation electronic repository in accordance with site SOPs.
- Understand the file structure on GMP documentation electronic repository and ensure all documentation is uploaded to the correct locations.
- Technical review of documentation prior to transferring from contractor document control platform to GMP documentation electronic repository.
- Development of certification traceability matrix detailing locations of certification referenced in IQ execution.
- Raise changes for revision of CQ documentation in accordance with the site SOPs.
- Report issues for escalation where agreed pre and post approval review and approval turnaround times are not being adhered to.
- Generate CQ test documentation as required on KNEAT platform.
- Review of executed IQ against GMP documentation uploaded on GMP documentation electronic repository.
- Drive completion of review and approval of executed qualification documentation within the agreed review and approval turnaround timelines.
- Coordination of handover of systems from CQ team to site team, including generation and approval of Project Handover forms.
Requirements:
- Bachelor's degree in a relevant life science field (e.g., biology, biotechnology, biochemistry). ·
- Min. 5 years of relevant document controller and change control experience.
- Excellent communication skills, both written and verbal, in English.
- Ability to multitask and work in a fast paced environment with competing priorities.
- Great team player. Strong interpersonal and communication skills and ability to develop close working relationships and work collaboratively with internal and external contacts at all levels
What’s In It for You?
- Exposure to the major Pharmaceutical Companies in the industry.
- Annual leave benefits.
- Full Health coverage and benefits.
- Training and Development allowance.
What's Next?
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.
