Site Investigation Lead

Pfizer Singapore recruit permanent employees for manufacturing site expansion of PFIZER ASIA MANUFACTURING PTE LTD (PAMPL) in Singapore.

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.

Own and ensure robust and effective investigations related to quality and safety deviations/incidents site wide.

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.

The colleague might be assigned additional roles in the business excellence function for 20-30% of the time.

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.

Embrace the "one best way" philosophy by actively performing routine assessments and analysis of the site investigation system through the use of the Investigation Utilization Tool and the Investigation Maturity Scale, analyzing related metrics, seeking out trends and discussing opportunities regularly at the Site Quality Review Team (SQRT) meetings

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.

Play an active and impactful role to deliver flawless execution for respective process centric team (PCT) by updating performance against metrics, highlighting & resolving issues, with appropriate escalations

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 goals

Ensure 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.

Work closely with investigations network teams to identify opportunities for system improvements, review proposed updates, and communicate planned changes to site QTS users

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.

Strong experience and passion to find root cause and effective CAPA for all type of investigations (Manufacturing, Laboratory, Product Complaints and EHS)

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