Deviation Mentor - Parenteral Manufacturing

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Organization Overview:
The Deviation Mentor is a member of the IPM Quality organization that educates, mentors and guides deviation investigations and analytical investigators.
The Deviation Mentor is also responsible for the training program associated to deviation system and may leads deviation review boards, participates in deviation assessment review pre-approval and post-approval.
The Deviation mentor leads the site metrics related to deviation system.
He/she can also lead complex investigations.
They participate in regulatory inspections and collaborate in the site inspection readiness program and assist and advice the lead investigators, functional leaders and Site Quality Leader and Quality Directors in issue investigation matters.
Responsibilities:
Provide advice and guidance to lead investigators in deviation investigation and analytical investigations (assessment, quality impact evaluation, root cause analysis method), investigation write-up (technical writing), support data, CAPA establishment and effectiveness.
Coach the deviation review board:
review of deviations prior to deviation approval.
Provide advice and assist deviation reviewers and approvers on issue investigation matters.
Owns the elaboration and reviews of deviation trend reports.
Facilitates the implementation of DRB Playbook at the plants and site level and connect plant /site metrics, trending and procedures with its implementation.
Establishes linkages with network and global teams and participate in relevant forums, such as global deviation CoP, ensuring the communication and implementation of best practices within the site.
Lead the review of the quality of deviation investigations (post-approval).
Design and elaborate site deviation metrics.
Participate in the review of plant deviation trend analysis.
Integrate global initiatives and/or projects related to the deviation management program into the site quality standards and processes.
Design and deliver deviations related to deviation management training programs.
Escalate concerns/issues and develop mitigation plans.
Trained as a lead investigator, deviation assessor and approver.
Can act as a technical reviewer for deviation investigations and analytical investigations.
Can approve deviation investigations, either as technical or quality approver, including minor and moderate deviations.
Can Lead complex investigations.
Ensures procedures, tools, and templates are in place (as applicable) for consistency and sustainability.
Participates on plat /site CAPA effectiveness program evaluation.
Ensures trends are timely identified and investigated to prevent recurrence.
Coach individuals on inspection interactions.
Collaborates in regulatory inspections, assisting in the preparation of key quality and compliance topics for audit and inspection readiness.
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
Basic Requirements:
BSc or MSc in a scientific or technical degree (chemistry, biology, microbiology, engineering or equivalent scientific/technical degree).
5 years of experience in deviation management and analytical investigation experience in pharmaceutical industry, parenteral manufacturing experience preferred.
Additional Skills/Preferences:
Experience in TS/MS, Engineering, QC and/or QA is preferred with expertise on parenteral products manufacturing.
Excellent technical writing skills.
Strong Influencing skills and interpersonal and teamwork skills.
Strong self-management and organizational skills.
Demonstrated successful cross-functional teamwork.
Critical thinking skills.
Good knowledge of cGMP, external Regulations and Quality Systems requirements.
Excellent communication skills.
Additional Information:
This is an onsite role based in Indianapolis, Indiana.
Travel (domestic and international) may be required (less than 10%).
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