Tuas Ii or Project Role

5 days ago

Singapore PFIZER ASIA MANUFACTURING PTE. LTD. Full time

10 years exp

**Roles & Responsibilities**

summary

The incumbent is a member of the Quality Assurance team supporting operational readiness of a new site extension.

Reporting to the Tuas II Operational Readiness Quality Lead, the incumbent will be responsible to provide Quality

Assurance oversight for the strategy and implementation of Alarms and Data management in automation systems (Delta

(comprising of personnel from Project, New Product Introduction, Production, Automation, Digital, and Quality

Assurance), ensuring systems are set up in compliance with Pfizer Quality Standards (PQS) and meeting regulatory

expectations.

**Responsibilities**:
Lead and provide direction from Quality Assurance perspective to project and site operational readiness teams for

Alarms and Data management in automation systems (Delta V, Catalyst).

Responsible for ensuring Alarms and Data management in automation systems are developed and set up to comply

with PQS requirements.

Review and approve GMP documentation related to Alarms and Data management in automation systems (e.g.

qualification plans, procedures, risk assessments, gap analysis).

Enhance site personnel’s knowledge of Alarms and Data Management in process automation systems and recipes

and PQS requirements.

Play an active and impactful role to deliver flawless execution through critically reviewing systems, processes and

interdependencies for GMP compliance and sustainability in routine operation.

Collaborate with cross-functional teams to drive flawless execution.

Uphold Pfizer's code of conduct and values.

Job Related Requirements:
Thorough knowledge and understanding of Alarms and Data management in automation and/or process recipe

systems (e.g. DCS, PLC systems, Catalyst) and appreciation of operational workflows in Active Pharmaceutical

Ingredient (API) manufacturing.

Thorough knowledge of Quality, Data Integrity requirements and regulatory expectations related to Alarms and

Data management in automation and/or process recipe systems.

Minimum 10 years of related experience in pharmaceutical manufacturing (including Quality Assurance roles), and minimum 5 years supervisory experience. Experience in API manufacturing is preferred.

Related experience should be in GMP-regulated industries with comprehensive knowledge in Quality Systems (e.g. Batch and Electronic Records Review, Change Control, Deviation), pharmaceutical industry trends and practices.

Degree in Science / Engineering or a related discipline.

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