YOUR TASKS AND RESPONSIBILITIES
Support implementation of automated manufacturing technologies.
Approval of User Requirement Specifications for manufacturing, testing and packaging equipment. Collaborate on the development and approval of Process instructions and SOPs related to product quality with Process engineering and manufacturing.
Develop IPC instructions.
Active participant in the development and completion of Risk analysis and Gap assessment. documentation for manufacturing operations, material transfer, analytical methods, mfg.
equipment, computerized systems, and training for assigned products.
Work together with other internal functions and SMEs with the development of validation packages (IQ, OQ, SV, PQ) and Test method validation.
Coordinate execution of said activities and reporting.
Support development of Master Validation plans and pFMEA.
Assist in the preparation of comprehensive project proposals including capital, expense, manpower and schedule estimates with a clear map to the long-term business impact.
Participate and be Quality Lead in Technical Transfer Review sessions aimed to obtain approval to start.
Engineering / technical’ s runs, start of Process performance qualification, and demonstrate product / process transferred is ready for regulatory submission.
Lead development and validation of test methods and transfer of test methods for In Process Controls performed in Shop Floor.
Ensure readiness for Operations based on project timeline.
Responsible to define, acquire and validate the quality In Process testing equipment and corresponding software as well as ensuring maintenance and calibration activities.
Responsible to create Quality Master Data for QM Module in SAP related to In Process Control Tests.
Responsible to send sampling tests to Sending Site and retain sample (pre-sterile and non-sterile), handling and related documentation.
Support transit test studies and conduct stabilities studies.
SME responsible for quality product related documentation.
Responsible to implement short term, mid-term and long-term quality capacity planning.
Responsible to hire, train, guide and lead quality inspectors.
Provide appropriate initial and continuing training for the quality inspectors.
Team member to track progress and escalate to Quality lead, if needed.
Performs other duties and tasks as required to support program / project development leading to and through operational start-up and sustainable commercial operation.
WHO YOU ARE
Bachelor's degree in Engineering is a must.
5+ years of experience in Quality Engineering activities (Shop Floor), process / software validations and technology transfer.
Experience in Process Validation and Software Validation according to GAMP 5.
Knowledge on analytical method validation process.
Knowledge of federal and international medical device / pharma.
Advanced English level, both written and spoken.
Strong Statistical Techniques Knowledge.
Prior managerial experience. (Preferred)
Knowledge in Technology Transfer.
Knowledge in Failure Analysis and Risk Management.
Demonstrated advanced problem-solving abilities.
Experience with automated assembly and packaging of pharma products.
Proficient with Microsoft Office tools.
Experience as Internal Auditor. (Preferred)