Validation Specialist

**Validation Specialist****YOUR TASKS AND RESPONSIBILITIES**- 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 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.- Perform investigation of deviations incl. OOS/OOT results or discrepancies related with the manufacturing (production and packaging) process validation to determine the root cause and propose corrective actions in the agreed timeline.**WHO YOU ARE****Education**- Bachelor degree or higher, preferable as apothecary/specialist**Relevant experiences**- Min. 3-5 years experience in pharmaceutical manufacturing industry**Main competencies for the jo**b** (Core, Leaders, technical competencies)- Good communication skill- Able to work as individual and in team- 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**:- 27 March - 7 April 2023**Reference Code**:- 787837**Division**:- Consumer Health**Location**:- Cimanggis Factory**Functional Area**:- Quality**Position Grade**:- R11**Employment Type**:- Regular**Work Time**:- Flexi Hours - 8 working hours**Contact Us****Address****Telephone****E-Mail**- PT Bayer Indonesia- Menara Astra, 33rd floor- Jl. Jend. Sudirman Kav.5-6, Jakarta 10220, Indonesia+622130491111