Responsible for providing technical expertise to the Production team. Responsible for providing appropriate training to the manufacturing team to ensure level of process and product understanding is contained.
- Provide technical input into validation activities for the Production team – write, review, approve and execute studies as required.
- Work alongside internal & external functions to transfer new equipment and techniques effectively & efficiently to production scale.
- Active participant for site Operational Excellence initiatives. To foster and encourage Continuous Improvement within the Production department. Lead process improvement initiatives and activities to influence change.
- To actively maintain and update knowledge and expertise of current developments, standards and operating practices within the biotechnology and pharmaceutical industries
- Input into the Regulatory strategy and author the relevant sections of Regulatory dossiers to support both Changes & Deviations.
- Ensure practical training modules are in place so that new starters within the teams are provided with sufficient background understanding and knowledge before entering their roles. Responsible for the provision of training to new starters and for robust re-training modules to maintain a high compliance within the teams.
- Provide subject matter expert input to Regulatory, internal, and external audits.
- Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with company values.
- Carry out other reasonable tasks as required by the Line Manager.
- o The above duties and responsibilities are not an exhaustive list, and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.
Education and Experience
- Educated to degree level in an appropriate scientific discipline desirable.
- Experience in a biopharmaceutical or closely related industry desirable.
- Understanding of cGMP legislation
- Computer literate.
Skills and Attributes
- Good technical background with a working knowledge of GMP, Quality and Regulatory understanding – desirable.
- Must have good listening/communication skills and be able to carry out investigations by gathering information from others.
- Needs to be methodical, organised and show attention to detail. Organisational skills should be strong with an ability to plan.
- Strong technical writing skills
- Ability to communicate effectively at all levels.
- Ability to work under pressure and co-ordinate several activities concurrently.
- Project management capabilities – desirable.
- Strong presentation skills
- Logical and numerate with an aptitude for detail.
- A keen strategic thinker who is willing to apply new concepts and ideas to take the business forward.
Applications are encouraged from all sections of the community.