Job Description
Our client a pharmaceutical manufacturer now seeks a QA Team Lead for Stability deviations who will report to the QA Compliance Lab Lead. This role will manage the work performed by the technicians creating and processing stability deviations.
The successful candidate will manage the stability deviations program including all commercial and validation stability deviations on relevant products on site.
This is a permanent role based in Connaught.
Responsibilities of QA Team Lead, Stability Deviations:
Organization of meetings with specific sites and Business Units regarding stability deviations generated on both commercial and validation studies.
Compile agency investigation reports and coordinate notifications to management and regulatory agencies.
Track status of open investigation with the relevant manager and ensure committed agency timelines are adhered to.
This person will also act as technical reviewer for global change controls associated with stability shelf life determinations.
Verification that project leaders have been informed of all stability failures associated with validation stability studies.
Communicate KPI as they pertain to number of open stability deviation.
Motivate key stakeholders to drive appropriate corrective actions and investigation activities.
Hold progress meetings with relevant team members.
Actively participate in the training and certification of new team members.
Provide required data to support stability deviation investigations and site decision making processes.
Provide review and approval of local and corporate documents.
Ensure that the stability deviation program is up to date at all times, across all Labs.
Ensure all activities are completed in line with regulatory (QA and EHS) and corporate requirements.
Requirements for QA Team Lead, Stability Deviations:
Bachelor?s Degree in Science is preferred.
Proven track record of Lab GMP and GLP standards.
3+ years Stability experience in Pharma/Medical Device environment ? FDA regulated.
Experienced in dealing with audit bodies, audit facing experience is required.
Driven individual, need to drive deviation investigations to completion.
Proven track record in project management.
Excellent communication skills.
Please contact Larry on 01-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website http://www.rftgroup.ie/
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