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Investigations Sme

3 weeks ago

Tuas, Singapore Pfizer Full time

**Why Patients Need You**:At Pfizer, our mission is to inspire a best-in-class culture of continuous improvement and project management that empowers colleagues and enables simple, effective processes. Whether you are managing projects or liaising with others, your contribution in this team will help in making our work easier and faster so that we can deliver breakthroughs that change patients' lives.

**What You Will Achieve**:This is a secondment role for setting up the quality and safety investigations system and culture at the new manufacturing API manufacturing facility in Tuas.

This role will work closely with the Site Investigations Lead, Department leads and PCT Investigation responsible person in all the functions related to operations (e.g. Production, Engineeing, Quality, Engineering and new products introductions).

This role is instrumental in developing the overall site investigations strategy for reducing repeat manufacturing investigations, influencing site leadership.

Contribute to achieve our vision of being the best in class manufacturing site, producing highest quality products in the safest way

**How You Will Achieve It**:

- **Site Investigation System and Strategy**
- Develop 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.
- Roll out the "one best way" philosophy including but not limited to content guides, templates and Investigation Maturity assessment tools
- Work with site leadership and partner with functional colleagues (quality, production, engineering, Technical Leaning & Capability, EHS etc.) to develop a robust site strategy and action plans for improving the Investigation system, as areas of opportunity are identified.
- Set up systems for effective tracking (e.g via incident board), completion and escalations of milestones for completion of investigations as per the IMEx principles.
- **Capability Building and Site Collaboration**
- Identify, coach and certify the required number of investigators and approvers site wide (post start-up).
- Implement the Investigations Training Curricula for quality deviations investigations
- E nsure 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 methodology are consistently used, inc l uding DMAIC methodology (M1/M2/M3)
- E nsure adequate root cause analysis (RCA), effective CAPA, to prevent repeat deviations and PHP (Pfizer Human Performance) to reduce and prevent human factors resulting in e rrors.
- Accountable for all the sitewide performance metrics related to investigations, such as repeat QAR’s, QAR closure on time etc.

**Qualifications**:**Must-Have**:

- Bachelor degree in Engineering, Science or related discipline from a recogn i zed university
- 10+ years of ex p er ien ce in a pharmaceutical industry with extensive hands on expe ri ence in developing and s u ccessf u l l y driving/strengthening site investigations st r ategy/ culture, and a sustained mindset for inn ovatio n & c h ange
- Expertise in a ll type of investiga t ions ( ER/QAR, LI R s, Complaints a nd E H S)
- Expe ri e n ce with relevant QTS modules & train e d on QAR inve stiga tor c urr i cula
- Trained on PHP and Qua l ity Risk M a nagement (QRM)
- Six Sigma Yellow Belt certified
- Demonstrated business acumen, experience in managing projects teams, programs, or workstreams of varying levels of complexity
- Strong interpersonal and influential skills
- Ability to effectively coach and mentor colleagues
- Strong oral and written communication skills
- Demonstrate ability to act decisively and independently to resolve issues
- Possess a can-do / pride to succeed attitude
- Embrace the use of digital technology to scale and speed up every form of interaction and action
***Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.**

**Continuous Imprv and Proj Mgmt