Total 2 job vacancies by Index Career Consultants Pte. Ltd.

Candidate with strong QA background in API/Bio manufacturing plant and experience in external inspection management and internal audit

Main responsibility/scope:

- Conduct Internal audit, audit CAPAs follow-up (discussion of response) and management of open audit CAPAs

- Support external inspections (logistics and backroom support)

- Quality review of documents related to Data Integrity (Audit trail review, data integrity risk assessment, ERES assessment, Data Mapping)

- Support for other areas (Quality risk management, QMR tasks and regulatory submission) in terms of management of open tasks, revision/routing of documents

- Event organization and/or other administrative tasks as assigned by Manager/Delegate.

Requirements:

-                      Experiencein internal audit and external inspection

-                      Atleast 6 years experience in GMP manufacturing operations (API/Biomanufacturing)

-                      Strong knowledge in Engineering operations, OT and IT systems (DeltaV, MES system,SAP, LIMS etc) and system interface

-                      Strong knowledge in Data integrity and Data governance principles          

-                      Quality and Compliance mindset

-                      High adaptability and ability to lead and work with cross functional team

-                      Strong communication and writing skills

-                      Teamplayer

Operational and Technical

• Responsible for execution of batch manufacturing instructions in accordance with pre-defined procedures and training.
• Ensures batch execution is performed with adherence to process critical steps and ensures flawless execution.
• Provides inputs on operational and process related improvements to achieve site business targets and manufacturing excellence.
• Performs technical verification of batch related recipes (POMS and DeltaV), manual operations and adhoc manufacturing documentations.
• Provides input in design of manufacturing recipe in DCS.
• Participate in digitalization projects and identify areas for process and operational streamlining.

Safety

• Adheres to safe work environment in accordance with regulatory and global/local EHS policies.
• Participates in safety risks assessments or participates in process hazard analysis as an operations representative(PHA).

Quality

• Actively resolve batch related document errors in a timely manner.
• Communicates all events/issues effectively with relevant stakeholders.
• Provide inputs for investigation – impact assessment and appropriate CAPA.
• Ensures overall plant upkeep during the shift and ensuring plant is always in audit ready mode.

Schedule

• Oversees deliverables ahead, anticipates complexities and prevents potential delays.
• Ensures processes are running as per planned schedule with minimal delays. Highlights effectively to shift supervisor if delays are expected.

Qualifications

• Diploma in Chemical Engineering/Chemistry or equivalent technical related diploma is required.
• Experience in working in API Plant with GMP manufacturing environment.
• Able to work comfortably in 12-hour rotating shift (Day/Night).