Hanan Medicare Hiring! Full Time Executive, Technical Service (Hanan Manufacturing) in Selangor, Earn up to MYR 4,000 - Ricebowl

Technical Service Responsibilities (Sterile Facility Project)

1. User Requirement Specification (URS) Development

• Prepare, review, and manage URS for sterile manufacturing systems including but not limited to; Aseptic filling lines, Isolators, Autoclaves and sterilization equipment, Depyrogenation tunnels, Cleanroom and HVAC systems, Critical utilities (Purified Water, Water for Injection, Clean Steam, Compressed Air), Environmental Monitoring systems, Laboratory and support equipment
• Ensure URS complies with GMP, aseptic processing and regulatory expectations.
• Coordinate with Engineering, Production, QA, QC, and vendors during URS finalization.

2. Facility, Utility and Equipment Qualification

• Support qualification activities including but not limited to; Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
• Support cleanroom qualification including but not limited to; Airflow visualization (smoke study), HEPA filter integrity testing, Cleanroom classification & Environmental monitoring qualification.
• Prepare and review qualification protocols and reports to ensure compliance with URS and GMP.

3. Validation Activities

• Prepare and support execution of validation protocols including but not limited to; Process Validation (aseptic process simulation / media fill), Cleaning Validation, Sterilization Validation (Autoclave, SIP, dry heat sterilization), Utility Validation (WFI, Clean Steam, HVAC) & Hold Time Studies
• Compile and review validation reports.

4. Technology Transfer and Process Implementation

• Support technology transfer for sterile products from development partners.
• Review technical documents including but not limited to: Process flow diagrams, Batch Manufacturing Records, Critical Process Parameters (CPP), Critical Quality Attributes (CQA) & Comparability.

B. QA QMS Responsibilities (Sterile Facility QMS Establishment)

1. QMS System Development and Implementation

• Establish and implement sterile facility QMS including Deviation Management, CAPA Management, Change Control, Risk Management (ICH Q9 principles), Document Control & Investigation system.

2. SOP Development and GMP Documentation

• Develop and review SOPs related to; Aseptic manufacturing operations, Cleanroom gowning and behavior, Environmental monitoring, Equipment qualification and validation, Sterilization processes, Contamination control strategy (CCS)
• Ensure compliance with sterile GMP and data integrity requirements.

3. Change Control and Risk Management

• Initiate and manage change control related to; Facility design, Equipment and utilities, URS and system implementation
• Conduct risk assessments (FMEA, risk ranking) related to sterile processes.

C. GMP Inspection Readiness and Project Compliance

• Support establishment of sterile GMP systems prior to regulatory inspections.
• Ensure compliance with Annex 1 GMP requirements for sterile manufacturing.
• Support regulatory inspections and partner audits.
• Ensure all facility, equipment, and QMS systems are inspection-ready.

Pay: RM2,800.00 - RM4,000.00 per month

Benefits:

• Additional leave
• Health insurance
• Opportunities for promotion
• Professional development

Work Location: In person