Recruiting Bio-pharma Process Manager (BPM) to join a Global Biopharmaceutical Company
Main responsibilities:
- Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements
- Responsible for maintaining the master manufacturing documents of assigned products (e.g. Master Batch Record, Bill of Material (BOM) & Recipe, Quality Risk Assessment, Zurich Hazard Analysis)
- Ensure that all critical parameters are within written Instruction
- Ensure that all process changes in assigned products are managed through appropriate change control procedure
- Ensure creation of production SOPs and Master Batch Records
- Act as Subject Matter Expert (SME) for the product and process knowledge; be highly knowledgeable of product and process trends by providing input to APQR for analysis and for driving process technology innovations
- Collect data for ongoing process verification (OPV), support product steward in tracking and evaluation of product performance and implementation of CAPAs
- Perform first line evaluation of product and process related issues (deviations, complaints, OOS, OOE)
- Support product steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy
- Maintain processes at inspection readiness level
- Support process optimization establishment and new technology introduction for continued productivity improvement, as appropriate
- Review validation protocols and reports for technical correctness
- Support the execution of process validations, and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution
- Responsible for creating the master manufacturing documents of assigned products, as appropriate
- Be knowledgeable of process design by providing input during process transfer
- Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables
- Support technology trainings and education programs for production operators
Candidate’s Requirements:
- Bachelor/Master’s degree in Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree
- Preferred experience in a managerial role within the pharmaceutical industry
- A minimum of 10 years of working experience process support role on the shop floor of GMP manufacturing and/or QA/QC.
- Proven process understanding (Pharma, GMP, Regulatory aspects)
- In-depth knowledge of regulations and guidelines (FDA, EMA, ICH)
- Confirmed understanding of project process management tools and methodologies
- Must be detail oriented as well as exhibit strong organizational skills
- Experience working with cross-department stakeholders
- Working expertise in HAZID, HAZOP, PSSR, Aspen Simulation, Distillation systems and processes
- Experience working in API facilities, Bio-Tech/ Bio-Pharma facilities
- Must anticipate needs and problems while crafting solutions
- Analytical thinking and problem-solving ability
- Ability to interact with other departments / disciplines
- Experienced in the supervision of personnel and team working
- Budget and cost control experience
- Flexible and able to comply/adapt to company and client requirements
- Confident and able to work on own initiative
- Offshore / Onshore experience in similar role
- Demonstrates a commitment to safety
- Must be Able to Work at site / offshore as and when required
- Knowledge and use of planning systems
- Delivery focused and committed to achievement of project goals
- Self-time management
Salary: SGD 10,500 to SGD 12,500
