We are seeking a Technical Document Specialist who will act as the technical document SME in support of Cambridge Pharma Limited (CPL) activities for project lifecycle from technical transfer through to manufacturing.
This role will also assist the Engineering and Manufacturing departments, and collaborate with other CPL departments, in the correct identification and completion of appropriate project and process documents and ensure all stages of project delivery are fully compliant with CPL and Oval Medical Technologies (Oval) Business System requirements.
- Be the single point of contact (SPOC) between Engineering and Manufacturing departments and Quality for CPL document requirements.
- Manage and maintain Engineering and Manufacturing departments documents in-line with CPL QMS requirements, ensuring they are fit-for-purpose.
- Own the process of updating Engineering and Manufacturing departments procedures and associated templates, reviewing changes with CPL departments.
- Liaise with the QMS document controller to ensure updates to procedures and associated templates are managed in a timely manner, including any required obsoletion.
- Provide cross-function and cross-project oversight of CPL document requirements in support of new project introduction activities for customer projects against current CPL QMS policy and procedure.
- Walk the processes to ensure understanding, completeness and accuracy of the process defined.
- Provide continuous improvement feedback on Engineering and Manufacturing departments policies and procedures as well as support to wider CPL Departments interdependent QMS documents.
- Work with CPL and Oval project teams to ensure correct completion of high-quality documentation in a timely manner and enforce consistency and best practice across CPL operations.
- Work with PMO to ensure that relevant documentation is produced by SME’s / Technical Project Leads in line with project plans.
- Where required, participate in the preparation for, and the undertaking of, internal and external audits ensuring compliance to Oval / CPL QMS policy and procedure.
- Other duties as may reasonably be required.
You should have experience in the following:
- Developing and maintaining quality management systems documentation in a pharmaceutical manufacturing environment.
- Cross functional working across projects within a pharmaceutical manufacturing environment.
- Developing procedures that comply with the requirements of GMP and ISO 13485 quality systems.
- Working in a small to medium size company.
- Formal relevant qualifications or a suitable level of relevant experience within a pharmaceutical manufacturing environment will be considered as equivalent.
We are also seeking the following:
Comfortable with attention to detail and adherence to procedures.
- Proactive approach to seeking opportunities to improve processes and documents.
- Ability to work with other departments and influence outcomes to meet business needs.
- Understanding of how to work to the requirements of the requisite industry standards and regulations.
- Excellent communication skills.
- Able to represent the company at meetings with customers and external agencies.
- Team player
If you are interested in applying for this position, please send a CV and covering letter setting out why you would be suitable for this role, to firstname.lastname@example.org with the subject line “Technical Document Specialist”