BDS Manufacturing Specialist
- Dublin
- Permanent
- Full-time
- Perform technical writing to edit and create documents to support Biopharmaceutical Manufacturing Operations. Documents will include Standard Operating Procedures, Work Instructions, Competencies, Master Batch Records, Training Packs, Protocols, Reports, Forms and other written materials.
- Raise, own and participate in change controls while meeting the regulatory requirements defined in relevant health authority submissions, cGMPs and local Health and Safety requirements.
- Assist with management of Change Management and Deviation Management monitoring systems.
- Ownership of Operations related supplier issues (SCAR's/SICAR's).
- Identify, own and drive improvement projects for the BDS facility and its supporting processes and functions.
- Participate and/or lead risk assessments for the BDS technical and
- Participate in inspection readiness projects and support internal audits and health authority inspections.
- Collate routine metrics.
- A minimum of 2 years' experience in Manufacturing Operations in a Pharmaceutical or Biopharmaceutical company, ideally with experience in both upstream and downstream processing.
- Good knowledge of GMP/HPRA/FDA regulatory requirements.
- Strong technical writing skills.
- Self-starter with strong communication, problem-solving and presentation skills.
- Ability to work effectively in the cross-functional environment as well as independently on a consistent basis.
- Work collaboratively in a matrix environment.
- Proven ability to work well as part of a team and on own with minimum supervision.
- BSc or MSc in Chemical Engineering, Bioscience, or Biotechnology.