Quality Manager (Batch Release & Validation)
1. Job Purpose
To ensure that products released for sale have been manufactured and packaged in accordance with the licensing requirements, Good Manufacturing Practice and business requirements; and to promote quality/compliance within area of operation.
To deputise for QP as required.
Expert / specialist knowledge of GMP and relevant OQ experience.
3. Principal Accountabilities
Manages an effective Product Release Service which ensures that all products released for sale or further processing have a quality appropriate to their intended use i.e. comply with Company GMP standards and Product Quality Specifications.
Leads and directs on complex investigations into deviation from GMP and laboratory investigations ie LIRs, IPNs, involving more than two functional groups. Develops and agrees corrective actions arising from such incidents.
Deputises for QP
Authorises non-QA and QA Standard Operating Procedures
Approves BMIs/BDSs and other production related documents
Reviews and approves executed manufacturing documents for compliance and prepares for QP certification. Manages this activity to agreed Service Levels.
Approves out Of Calibrations, Critical Alarm Notifications, DCFs, Y3 notifications
Ensures that the QP and relevant Production Stream Management (as applicable) are notified of any deviations from GMP, which may have significant affect on product quality.
Provides GMP advice on an on-going basis and oversees operations ensuring GMP requirements and product registrations are adhered to.
Promotes Quality Improvement activities and contributes to improvement projects
Ensures that OQ staff in the area are aware of relevant Safety, Health and Environmental regulations and initiatives, COSHH surveys and safe working practice.
Authorises QA representatives on projects.
Provides OQ input to various aspects of Engineering functions specific to the area, e.g. Critical Device Rationales.
Provides quality input into vendor complaints
Delivers training across site, as required, in GMP standards (e.g. site induction training).
Trains and mentors Quality Officers, Quality Coordinators and Senior Quality Coordinators.
Provides quality input for change control activities, ie ECC, Planned Changes
Manages inspection readiness activities
Fronts third party and regulatory inspections
Routinely assumes team leadership duties for all OQ activities.
Manages activities arising from audits and serious incidents.
Participation in Validation exercises from a quality perspective. Including giving validation advice, managing planned changes, writing master plans and summary reports. Approval of the validation documents
Collates local data for Periodic Product Reviews (PPRs)
Collates Critical Alarm reports (6 monthly reviews)
Summarises trends in Non-batch related IPNs (annual reviews)
Supports the self inspection and business monitoring programmes
If requiring an adjustment for a disability, once selected for
Interview you may contact firstname.lastname@example.org
Closing date for applications: 19th May 2017
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you for your interest in this opportunity.
You may apply for this position online by selecting the Apply now button.
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