- Handling inspection of packing materials by ensuring that the processes are conducted according to the established procedures. Further, continuously reviews the SOPs used in this field to be up-dated as required to be in line with the up-dated quality guide and Bayer specifications.
- Support QA in releasing process of packing materials by providing data in Laboratory Work Sheets as well as in the system.
- Any non-conformity of incoming materials observed during analysis should be informed to QC Manager or head of Quality to take action and decision.
- Support Packaging Team to overcome non conformity due to quality issue by providing related data.
- Perform laboratory investigation for OOS cases and support Supplier Qualification Team in dealing with suppliers of packing materials to encourage them improving their quality by providing data needed.
- Define priority of testing by coordinating with Supply Change Management and control the Packing material and stability instrumentations are in qualification status & calibration period.
- Follow safety regulation for every step of analysis when performing analysis and control the packing material lab., stability chamber area are clean and tidy in order to HSE aspects.
- Contribute actively on Operational Excellence and Complexity Reduction programs.
- Manage all stability study sample includes maintenance of chamber and availability of stability lab worksheet and reports.
- Provide stability report and ensure the flowing of stability report, if needed coordinate
- Support the QC Manager to perform Operational Excellence program and Reduction Complexity program for efficiency purpose.
- Bachelor degree major in Pharmacist, chemical or Industrial Engineering.
- Having experience in packaging materials analysis and stability management for minimum 2 years or 2 years supervisory level in packaging materials from other companies as a minimum.
- Familiar with SAP
- Understands know how on current GMP as well as other relevant national and international regulations for pharmaceutical products (GMP codes).
- Skilled, saving and critical in carrying out their duties and take notice provisions on hazards in the work environment and about environmental control.
- Skilled to work within an international team and has ability to work within team. Be able to resist any influence, which would hamper management decision making.