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A Bulk Drug Substance Manufacturing facility are in need of an experienced QA Validation Engineer who has knowledge of both Upstream & Downstream processing to execute the site QA activities from start-up to commercial readiness.
You will be working closely with various departments such as Operations, QC, Facilities, Engineering and Supply Chain. This will also involve effective interaction with other departments & locations regarding GMP Document review and finished product releases. So excellent communication skills will be required!
Duties will involve:
- Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition.
- Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert.
- Review and approval equipment/utilities verification documentation from design to post execution.
- Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
- QA support for implementation of Manufacturing Execution System (MES) computer system validation deliverables.
- Review and approval of engineering functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
- Authoring, review and approval of QA-related procedures.
- Oversee the effective documentation and tracking of quality management system activities including deviations and change controls and CAPA.
- Review and approve Validation protocols as required. (Examples include cleaning, process, method validation).
- Participate in regulatory inspections as required
- QA experience in a pharmaceutical manufacture/bio-pharmaceutical environment- Bulk drug substance will be essential
- Must have strong process knowledge to include upstream and/or downstream processing.
- Excellent communication & presentation skills are essential.
- Excellent time management organizational skills along with a proven ability to malti-task.
- BSc. in science/pharmacy with experience in cGMP Quality environment to include bio-pharmaceutical experience.
Call me to discuss this role in more detail !!
The candidate must have the rights to work in the location stated in the job advert.
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