Process Validation Officer
YOUR TASK & RESPONSIBILITIES
- Prepare validation documentation as per established VMP. The documentation includes creation risk assessment and/or protocol validation, report validations and other relevant documents (MBR Pas-X in [email protected] and MBRin LifeDoc, FORM BOM) and provide necessary administrative data collection, check for proper alignment of all documents for the manufacturing (production and packaging) process validation activities and document readiness for validationexecution including bottle sample preparation, print out MBR for validation and other required and relevant FORM.
- Support execution of manufacturing (production and packaging) process validation activities, including sampling and physical parameter test according to the protocol validation (including to support alignment pre and post validation) as per established Validation Master Plan (sVMP) and ensure validation sample are taken and sent to QC to be analyzed.
- Escort validation process (1st/2nd/3rd shift) to ensure the process follows validation protocol.
- Perform administrative data collection for process validation sub-department including OPV, assigned KPI/initiative and investigation of deviations incl. OOS/OOT results, nonconformity or discrepancies related with the manufacturing (production and packaging) process validation to determine the root cause.
- Follow up CAPA recommendation from manufacturing (production and packaging) process validation activities/event/deviation/risk assessment in [email protected] System, task of change management system and check to ensure the CAPA recommendation or assigned tasks are closed in timely manner.
- Create draft for standardprocedures (e.g. SOPs and templates) related to manufacturing (production and packaging) process validation topic in accordance with the updated requirements for the implementation in manufacturing (production and packaging) process validation area (e.g.: CMS, Bayer Regulation: GOI, GSOP, Supplement, Best Practices, Local regulation such as CPOB, PICs).
- Provide information status validation activities to support Validation Master Plans creation and update and support data compilation of Site Quality Management Reviews related to manufacturing (production and packaging) process validation areas.
- Complete training for relevant cGMP and required pharmaceuticals knowledge point of views, build trustful and honest working relationship and instill the right first time methodology.
- Implement appropriate precaution on occupational safety and health including HIRA (Hazard Identification Risk Assessment) of working area as well as security of facilities within Quality Department.
- Propose to initiate development needs and update the progress through regular one to one discussion (performance-based dialogue).
- Upgrade his/her-self in management and professional skills especially on validation and GMP requirements.
WHO YOU ARE
- Bachelor’s degree in pharmacy / Apothecary / Chemical Engineering / Industrial Engineering or related area.
- Having 1+ experience in GMP aspects related with food supplement or drug manufacturing/fresh graduate is still applicable.
- Having knowledge related with the manufacturing (production and packaging) process validation require
Application Period: 30/05/2022 Reference Code: 641282
Division: Consumer Health Location: Indonesia : DKI Jakarta Jakarta : Cibubur Jakarta
Functional Area: Production&Manufacturing Position Grade: R09
Employment Type: Temporary Work Work Time: Flexi Hours (8 working hours)
Address Telephone E-Mail
PT Bayer Indonesia
Menara Astra, 33rd floor
Jl. Jend. Sudirman Kav.5-6, Jakarta 10220, Indonesia [email protected]