Operational Quality Manager / Qualified Person
Reference: | SMC3849 |
Location: |
Tipperary
|
Qualification: | Degree | Experience: | See description |
Job Type: | Permanent | Salary: |
Not Disclosed |
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
Education & Experience
- 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.
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.