Operational Quality Manager / Qualified Person

We’re currently recruiting for an exciting opportunity with a pharmaceutical organization. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Ensures the batch disposition process maintains compliance with site practices & regulatory requirements.
• Support major investigations, ensuring all product deviations are closed prior to batch release.
• Reviews and approves Product Quality Reviews.
• Reviews and approves new and revised master manufacturing records.
• Participates in cross-functional teams as Quality/Qualified Person representative.
• Participate in third party/supplier audits, as required.
• Review annual customer complaints.
• Participation in any product recall or product defects.
• Actively contribute to continuous improvement initiatives.
• Conduct duties in a safe manner and report all safety issues and concerns.
• Complete all duties as per relevant SOP’s.
• Review of investigation reports.
• Review of validation protocols.
• Review of Quality Documentation as appropriate e.g. Bill of Materials etc.
• Work with relevant departments to ensure timely closure of Quality Actions / Findings.
• Provide additional QP support to quality related issues, as required

• Must meet the minimum training/education requirements for QP qualification
• Must have at least 5-7 years’ experience working within a Quality Assurance role
• Work experience acting as Qualified Person, named on a Manufacturing and Importation Authorisation (MIA) is highly desirable.