- Develop, review and update engineering, manufacturing, & inspection Standard Operating Procedures.
- Liaise with Manufacturing/Inspection/Engineering regarding documentation changes in an effective and timely manner.
- Develop protocols for execution in Manufacturing & Inspection in support of change controls, non-conformances & troubleshooting investigations with support from relevant SMEs.
- Involvement in projects as part of continuous process improvement and / or troubleshooting.
- Ownership of change controls for Manufacturing/Inspection/Engineering.
- Issuance and updates of paper batch records in line with production schedule.
- Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current OS.
- Support production support team in reducing document turnaround times.
- Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including SOPs.
- Provide technical and clerical support to the manufacturing, inspection & engineering teams in the preparation of documentation, collation of data and tracking of SOPs.
- Ownership of Level 1 non-conformances.
- Educated to degree level or equivalent.
- Significant experience in Chemistry/Microbiology/Engineering/Validation gained within a biotechnology, pharmaceutical or health care organisation.
- Experience with developing SOP’s, writing up non-conformances, change controls and CAPA’s.
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