PURPOSE & SCOPE OF THE POSITION
The Process Specialist contributes to developing Symbiosis’ mutually beneficial relationships by:
- Supporting and performing in the evaluation and technical transfer of manufacturing processes into the facility.
- Educated to a minimum of BSc (Hons)
- GMP pharmaceutical manufacturing
- COSHH / health and safety
- Familiarity with GMP regulations and documentation requirements and GMP quality systems
- IT Skills – Microsoft packages
- Formulation development
- Experience of a GMP controlled cleanroom environment
- Knowledge of pharmaceutical manufacture
- Process documentation generation
- Minimum of 2 years working in a GMP manufacturing environment
- Experience of technical transfer
- Experience in working directly with clients
- Positive aptitude for problem-solving
- Working effectively within a team
- Effective communication skills
- Accurate and timely documentation generation
- Ability to multi-task in a busy environment
- Flexible and adaptive team player with excellent organisational skills and high attention to detail
- Proven problem-solving and troubleshooting skills
- Ability to train others
- Client facing experience
- Practical ownership of projects
- Ability to supervise critical steps of manufacturing processes
If you would like to apply for this role, please send your CV and cover letter, detailing your salary requirements to firstname.lastname@example.org
- Providing support to the Technical Manager, Head of Manufacturing and Head of Technical Services in the introduction of new projects to Symbiosis
- Directly interacting with the Technical Supervisors and Team Leaders to ensure that projects are transferred into the facility within agreed timeframes and staff are adequately trained and informed of the process specifics to ensure the success of the project
- Supporting the timely procurement of all materials by directly working with Supply Chain Manager and escalating any issues to Technical Manager and Head of Technical Services
- Full responsibility for generation and technical approval of MTA’s and BMRs in support of the Technical Manager and Project Management Team
- Ensuring all relevant legislation is adhered to within the Technical department. Eg COSHH, Health and Safety at Work
- Maintaining control documentation and relevant Standard Operating Procedures in liaison with the Quality department
- Demonstrating a culture of continuous improvement and work with management to implement process improvements and positive change within the technical transfer process
- Providing training and cleanroom expertise to manufacturing staff and adopt a supervisory role within the cleanroom during operations
Compliance & Quality Management
- Ensuring that quality standards are achieved and maintained, taking ownership of non-conformances and CAPA’s as required and ensure that QMS documents are completed in a timely manner and provide wider support to the rest of the business as deemed necessary
- Actively participating in initiatives to increase compliance across the business
- Ensuring that GMP competency-based training and training file are maintained in an inspection-ready state
- Supporting the Technical Manager in internal training initiatives as required
- Fostering and maintaining professional working relationships with clients
- Participating in internal and external GMP audits
- Subject Matter Expert (SME) in designated areas of expertise in audits and inspections as required
- Attending, participating and contributing to regular staff and management meetings, as necessary.
- Investing in developing relationships with all staff to fully understand staff’s technical & process support needs and develop my colleagues accordingly
- Investing in developing relationships with the management team to ensure we are a high performing Technical team and Symbiosis’ services meet expectations.
- Acting as an ambassador for the company.
- Supporting the induction, and development of the staff to ensure they are clear about how they contribute to Symbiosis and can operate at their best.
- Understanding my team’s needs, capabilities and preferred ways of working, and provide them with support and feedback.