QA Validation Engineer - Biopharma
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
- Min 5 years QA experience in a pharmaceutical manufacture/bio-pharmaceutical environment- Bulk drugs 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 multi-task.
- BSc. in science/pharmacy with a minimum of 5 years’ 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.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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