SME Master Batch Record Designer

SME Master Batch Record Designer - PAS X
We are seeking an experienced SME Master Batch Record Designer to oversee and update MBRs based on manufacturing changes, participate in MBR design workshops and informal test runs, support and execute MBR verification protocols, provide HyperCare during site go-live, assist with end-user training, and support MES validation activities (IQ/OQ/PQ).
Oversee and update MBRs based on manufacturing changes.
Participate in MBR design workshops and informal test runs.
Support and execute MBR verification protocols.
Provide HyperCare during site go-live and assist with end-user training.
Support MES validation activities (IQ/OQ/PQ).
As MBR Designer:
Ensure MBR accuracy and compliance with manufacturing processes.
Create master data and manage object setup (status diagrams).
Adhere to global MBR design standards.
You have a successfully completed degree (biotechnology, biology, engineering).
5+ years of experience as MBR Designer with PAS-X 3.2 in the life sciences sector.
Proficient in both French and English (spoken and written).
Contribute to Life Science projects for Antaes Asia clients
Work with cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures.
Provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV Plan and 21CFR Part 11.
Act as one of the key focal points for CSV topics such as deviations, change management, investigations, CAPA identification and closure and as a
Subject Matter Expert
Generate, review and execute protocols / test case for initial validation programs related to GXP Computer systems. -e.g. Qualifications protocols – Software qualification, Input/Output loop verification, hardware qualification.
Review and approve qualification documentations like URS, SLIA (system level impact assessment)/ CLIA (component level impact assessment), SRA (System Risk Assessment), DIRA/ DSA (Data security, audit trail review), DQ, SIOQ, HIOQ, FAT, FATSR, Traceability Matrix etc.
Ensure adherence to CSV master plans and execution plans for GXP computer systems like DCS, PLC, BMS, MES, eBR, Lab Information systems, Environmental monitoring systems and other Business IT systems like Maximo, Network and ERP systems that are part of the GMP envelope.
Any other tasks assigned
Contribute to the promotion of Antaes services on top of assistance provided to clients
Contribute to Life Science projects for Antaes Asia clients
Lead a team of warehouse assistants in materials handling activities which include but not limited to receiving and processing of incoming materials, apply label to materials, move pallets, re-palletize materials, retrieve raw materials from cold rooms, return raw materials to pallets position.
Monitor and manage inventory control. Establish SOP for warehouse operation.
Oversee the daily coordination/planning for inbound and outbound activities to support smooth production execution.
Ensure accurate and timely receiving and issuance of materials to production from internal warehouse and 3PL to ensure no production stoppages (This includes Cold Room or Freezer materials).
Raising of materials damage report, materials disposition authorization and any other document to track the movement of inventories.
Lead and conduct investigation for any inventory discrepancies, violation of GMP and EHS procedures.
Lead and plan for routine cycle counting activities which may include physical counting, count check, count verify and data entry of count tabulation. Ensure all inventories are properly managed.
Ensure all documentation is handled, filed properly and data are posted accurately in the SAP system.
Responsible for all outbound land, sea and air shipments. Ensure shipments are pack and stuff on time for delivery.
Ensure all material handling equipment such as Forklift and VNA are operated with standard operating and safety procedures and also training of new employees.
Ensure safe and clean work environment by keeping shelves, pallet area, and workstations neat.
Involve in warehouse verification and qualification of equipment and area of applicable.
Ensure that all tasks performed follow Standard Operating Procedures (SOPs) and comply with Current good Manufacturing Practices (cGMP) principles.
Any other duties assigned by the Superior or Management.
Contribute to the promotion of Antaes services on top of assistance provided to clients
Contribute to Life Science projects for Antaes Asia clients
Manage the routine receiving of goods, including verification of shipments, checking delivery documents, and processing receiving documents for submission to the Quality team for approval if required
Update the JDE (JD Edwards) system with accurate receiving information to maintain up-to-date inventory records
Operate a forklift or reach truck to put away goods in the designated warehouse locations after clearance
Ensure safe handling and storage of goods in compliance with warehouse safety protocols and pharmaceutical standards.
Coordinate the