Lead Commissioning, Qualification and Validation support of CompanyProvide technical support to site Validation personnel, as well as work with Engineering and QA to ensure reliable and predictable equipment and process operation.In depth understanding of the governing standards for medical device sector.Collaborate with multiple departments including Manufacturing, Facilities, Engineering, Quality Control, Validation, Quality Assurance, and Regulatory to facilitate agreement on… Show more Lead Commissioning, Qualification and Validation support of CompanyProvide technical support to site Validation personnel, as well as work with Engineering and QA to ensure reliable and predictable equipment and process operation.In depth understanding of the governing standards for medical device sector.Collaborate with multiple departments including Manufacturing, Facilities, Engineering, Quality Control, Validation, Quality Assurance, and Regulatory to facilitate agreement on equipment and process operational parameters, test requirements and acceptance criteria.Own and Manage Change Controls to allow for the ongoing maintenance and optimization of Validated systems.Generation, execution and closeout of Commissioning and Validation documentation, including test plans, procedures and protocols.Review and approval of a variety of validation lifecycle documents, include but are not limited to validation and/or project plans, user requirement specifications, SOPs, maintenance documentation, investigation reports, deviation resolution, CAPA closeout, etc. Show less

Ensure production activity meet the regulation (CPOB, ISO 9001, ISO 45001 and Halal System Assurance)Ensure meet production schedule and project planISO 9001 Internal Audit ISO 45001 Internal AuditPrepare the SOP compliance with newest regulation and guidancePrepare the operator and perform adequate training

1. Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.2. Identifies and sets appropriate quality standards and parameters for products.3. Communicates quality standards and parameters to QA team, product development team, and other appropriate staff.4. Coordinates deviation, PQR, product release, validation and qualification within company.5. Coordinates audit internal and… Show more 1. Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.2. Identifies and sets appropriate quality standards and parameters for products.3. Communicates quality standards and parameters to QA team, product development team, and other appropriate staff.4. Coordinates deviation, PQR, product release, validation and qualification within company.5. Coordinates audit internal and external.6. Identifies and analyzes issues, bugs, defects, and other problems, particularly when problems recur in multiple products; recommends and facilitates solutions to these issues. Show less

- Provide oversight and leadership for manufacturing groups within the facility.- Responsible for ensuring employees in assigned areas work in a safe manner.- Responsible for the cleanliness of the production area.- Work with marketing, planning, purchasing and quality departments in the development of new products and packages.- Ensure that products made within the plant are produced in accordance with applicable local, state, and federal laws and regulations.

- Prepare machine and utility qualification protocol - Coordinate with colleague for preparation and execution machine/utility qualification.- Discussion with colleague related to qualification result - Prepare machine and utility qualification report (summary and recomendation)- Basic cGMP training for personnel- Perform annually weighing calibration