- Develop, review and update production Standard Operating Procedures.
- Develop, review and update master/generic batch records, bills of materials etc.
- Develop, review and update Product Quality Risk Assessments
- The Manufacturing Specialist will also function as the Manufacturing point of contact on
- New Product Introduction (NPI) Projects and be responsible for:
- Partnering with key functional groups to drive strategy definition for risk assessments, characterization, validation, regulatory, and filing milestones.
- Lead Product Team meetings.
- Ensure compliance with project milestones such as conformance batches manufacturing, regulatory submissions, and product launches
- Hold people to account for delivery and behaviours within Product team
- Function as the site interface between the Product Delivery Teams (PDT's), and ADL Senior Management.
- Author, Reviewing and Approving new training materials.
- Develop, review and update Protocols for manufacturing activities.
- Documentation and approval of protocol deviations for manufacturing activities.
- Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing.
- Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP's, batch documentation and licences.
- Liaise with Process Development regarding documentation changes in an effective and timely manner.
- Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including batch documentation, bills of materials and SOP's for submission to the Product Lead.
- Provide technical and clerical support to the production team in the preparation of documentation, collation of data.
- Own and lead change controls as required by the NPI Project Team.
- Bachelor's Degree in Science or Engineering and 3+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
- Detailed technical understanding of fill/finish operations
- Experience participating in and leading cross-functional teams
- Experience in managing multiple, competing priorities in a fast-paced environment
- Strong technical writing and presentation skills
- Ability to be flexible and manage change
- Ability to communicate and collaborate with technical and management staff
- Project Management experience
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