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Site Investigation Lead
2 weeks ago
This role is instrumental in developing the overall site investigations strategy and system for the new API manufacturing facility for reducing repeat manufacturing investigations, developing sitewide competency for investigations and influencing site leadership.
Strengthen the site investigation culture through coordinating, planning, assessing, and reporting investigation effectiveness for all safety and quality deviations.
Contribute to achieving our vision of being the best in class manufacturing site, producing highest quality products in the safest way.
Role Details
Site Investigation System and Strategy
Own and ensure a robust investigation process for the site, through the consistent and effective use of investigation system procedures and tools, and strong investigation culture across the site.
Work with site leadership and partner with functional colleagues (quality, production, engineering, technical learning, Environment Health & Safety etc.) to develop a robust site strategy and action plans for improving the Investigation system, as areas of opportunity are identified.
Ensures effective tracking, completion and escalations of milestones for completion of investigations as per the Integrated Manufacturing Excellence (IMEx) principles.
Work with the Business Excellence PCTs to identify and drive improvement as per the continuous improvement (CI) goals of the Business Excellence PCT
Capability Building and Site Collaboration
Implement the Investigations Training Curricula for safety and quality deviations investigations;
Ensure ongoing support, active coaching, and the use of the structured on-the-job documents for qualification of new originators/investigators/approvers and for those that may need additional knowledge and skills.
Ensure sufficient training and coaching resources are available and occur in a timely manner to meet site investigation goalsEnsure that all investigations training, tools and methodologies are consistently used, including DMAIC methodology (Ml/M2/M3)
Ensure adequate root cause analysis (RCA) is completed so that effective corrective actions and preventive actions (CAPA) can be designed to prevent repeat deviations
Ensure PHP (Pfizer Human Performance) is appropriately used to proactively reduce and prevent human errors.
Global Investigation Sharing
Attend, participate and contribute to global discussion groups related to investigations, and Pfizer human performance (PHP) sharing information between the groups and the site colleagues, replicating practices, and promoting/enabling site colleague participation.
Work as needed with EHS, Quality (QA & QC), technical learning, and Business Excellence SME's to keep up to date with activities regarding the Investigations system.
Accountable for:
Milestone adherence for investigations
Investigations closure on time
% Deviations with error proofing and error prevention
% Repeat Deviations
Right first time investigation (or equivalent metrics for assessing quality of investigations)
Qualifications and Experience
Bachelor degree in Engineering, Science or related discipline from a recognized university
6 to 8 years of experience in a pharmaceutical industry with extensive hands on experience in developing and successfully driving/strengthening site investigations strategy/ culture, and a sustained mindset for innovation & change.
Trained on human error investigations
Six Sigma Yellow Belt certified
Skills to translate and present visualization of data into a format that can trigger action and business decisions
Strong interpersonal and influential skills
Ability to effectively coach and mentor colleagues
Strong oral and written communication skills
Demonstrated abilit
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