Production Coordinator

2 weeks ago

Tuas, Singapore Pfizer Full time

To provide and issue controlled copy documents and technical administrative support to production.

To review and ensure documents and records are following Good Documentation Practice and regulatory compliance.

POSITION RESPONSIBILITIES
- Support production in the preparation, issuance, review and reconciliation of controlled copy documents required during startup and process campaigns.
- Support the preparation and issuance of controlled copy documents required to execute a changeover cleaning campaign (post-manufacturing instructions and cleaning instructions) in the plant with the Process Engineer (changeover).
- Support the review, reconciliation and ensure documentation completion of the changeover cleaning post manufacturing instructions and cleaning instructions of the equipment train.
- Monitor and maintain the production and changeover cleaning documentation on a proactive basis, whilst continually reviewing the systems and procedures to identify areas for improvement. These documents include, but not limited to cleaning instructions, post-manufacturing instructions, record of manual operations, forms and operation procedures.
- Co-ordinate the overall administration of the plant documentation in close liaison with the Shift Team Supervisors, Process and Operations Managers and the shift teams technicians.
- Support the Process Engineer (changeover) for project work, change control initiation and execution of actions related to the change control and project work.
- Back-up to the Process Engineer (changeover) for the changeover cleaning documentation and ad hoc documentation review for compliance to GDP.
- Responsible for department document coordinator/custodian.
- Support shift and process team as administrator for HEMA system.
- Support shift and process team on equipment and runner allocation.
- Ensure the changeover cleaning activities are executed as per site procedures.
- Issue controlled copies of the changeover cleaning documents, forms, operating instructions and log books to operations team.
- Co-ordinate changeover cleaning and liaising with QA team for release of cleaned equipment.
- Conduct investigations and safety investigations related to changeover cleaning or any other assigned operations issues.
- Conduct day to day review of forms and documents to ensure Good Documentation Practice.
- Coordinate with Tank Farm, EHS and Warehouse team on waste disposal information pertaining to waste generated during operation and changeover cleaning.

Accountable for:

- Monitoring & Completion of Plant and changeover cleaning Documentation.
- Plant and Changeover Cleaning Documentation Preparation.
- Plant and Changeover Cleaning Administration.
- Trend Reporting & Analysis.
- Changeover cleaning Documentation preparedness.
- Changeover cleaning on schedule.
- Metric measurement reports

Educational Requirements:

- Diploma in a technical discipline or GCE 'O/A' levels

Experience Required:

- At least 3 years experience in a relevant manufacturing and pharmaceutical environment. Fresh graduates without experience may be considered.

Core Competencies:

- Process & Plant Knowledge.
- Strong IT and reporting skills (e.g Excel, word).
- cGMP Knowledge.
- Personal & Organization Skills.
- Team player

Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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