- BBBH767279 Sep 29, 2020 Competitive
Senior Quality Auditor opportunity for a leading Biotech company
I am currently working with a leading biotechnology company that invents life-transforming medicines for people with serious diseases. This company are going through huge expansion at the moment and are on the lookout for a Quality Auditor to join their team on a Permanent basis.
This individual will be responsible for planning and conducting quality audits in a GMP manufacturing setting. The travel aspect of this role is on hold for now but there may be a requirement for up to 50% travel on occasions in the future.
Essential Duties and Responsibilities:
- Schedules, prepares, and conducts audits in support of GMP.
- Assembles and coordinates the activities of the audit team.
- Conducts audits in accordance with the company's standard operating procedures and quality policies.
- Interprets policies, standards, and regulations, and then evaluates potentially critical problems not covered by the policies, standards, and regulations.
- Compile inspection reports to include findings, corrections and process improvements.
- Track corrective actions and planned action agreements from inspections to closure.
- Participate in continuous evaluation and improvement of all quality aspects at the manufacturing site with particular emphasis on process systems and QMS.
- Ensures that written procedures are followed, and exercises judgment in evaluating quality systems, processes, procedures, and protocols for compliance.
- Escalates any compliance issues.
- Communicates audit results to management and auditees through written audit reports.
- Manages post-audit activities and follows up on any necessary corrective and preventive actions by resolving any conflicts.
- Assists with hosting regulatory facility inspections by acting as a scribe and/or document reviewer.
- Drafts and issues periodic reports to site management as requested.
- Assists with training/orientation for new Quality Auditing staff and supervises junior auditors.
Education and Experience:
- BSc with 2-5+ years of related experience in Biotech/Pharmaceutical industry
- 2-5 years of audit experience in GMP environment preferred.
- Solid understanding of Quality Management Systems
- Solid understanding of pharmaceutical/biopharmaceutical processes
If you would like more information, or would like to be considered for this role, get in touch with Kellie today on firstname.lastname@example.org or 021 2300 300
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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Consultant | Engineering Recruitment - Quality & Validation
353 (0) 21 2300300