Create the risk assessment and check for proper alignment of all relevant documents (MBR Pas-X in MES@CIM and MBR in LifeDoc, FORM BOM), for the manufacturing (production and packaging) process validation activities as per established VMP,
Perform collection the administrative data for process validation sub-department KPI and initiatives project, also necessary statistical data for evaluation to support process analysis.
Create standard procedures (e.g. SOPs and ROS/Centerline parameter) 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.
Perform investigation of deviations incl. OOS/OOT results or discrepancies related with the manufacturing (production andpackaging) process validation to determine the root cause and propose corrective actions in the agreed timeline.
Follow up the CAPA recommendation from manufacturing (production and packaging) process validation activities/event/deviation/risk assessment in Dev@com System, task of change management system and check to ensure the CAPA recommendation or assigned tasks are closed in timely manner.
WHO YOU ARE
Bachelor degree or higher, preferable as apothecary/pharmacist
Min. 3-5 years experience in pharmaceutical manufacturing industry
Good communication skill Able to work as individual and inteam
Good analytical thinking Have experience / knowledge in project management Have knowledge in statistics
Having knowledge in GMP principles, regulations, production and packaging process, stability, change management and material / supplier qualification
Application Period:
15/07/2022 - 25/07/2022
Reference Code:
687481
Division:
Consumer Health
Location:
Indonesia : West Java : Cimanggis
Functional Area:
Quality
Position Grade:
R11
Employment Type:
Regular
Work Time:
Flexi Hours (8 working hours)
Contact Us
AddressTelephoneE-Mail
PT Bayer Indonesia
Menara Astra, 33rd floor
Jl. Jend. Sudirman Kav.5-6, Jakarta 10220, Indonesia
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