QAV Engineer

QAV Engineer, Leading Manufacturing Facility, Ireland

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

Skills & Experience:

• 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.

Ideally you will be degree educated in the in the following:

• 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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