Purpose: Ensure GMP compliance in API Production areasResponsibilities and DutiesReview Batch Records directly during production phasesServe as liaison to production operators and shift leaders to provide support and guidance to ensure GMP complianceCommunicate with Facility Maintenance team members to understand the control of the production environment during specific events that may impact the quality outcome of APIParticipate in the initiation or completion of deviations investigations and risk assessments for product quality events to include conducting root cause analysis and performing interviews with appropriate employeesCollaborate in the drafting / revision of SOP and MBR, verify correct GMP application and alignment of performed operations with written instructionsReview all GMP documentation related to the production areaEvaluate change proposals and implementation Verify process documentation Ensure continuous auditing of production areasOversee correct application of equipment cleaning proceduresReview process validation, cleaning validation and equipment / facility qualification protocolsReport critical quality situations to supervisors, evaluate solutions and implement directives Propose and monitor implementation and effectiveness of CAPAs related to area of responsibilitySupport client audits both during on site visits and during drafting of CAPA PlansRequired Qualifications Must have direct experience with Quality Assurance within an regulated industry (USDA, FDA, ISO etc)Understands and applies comprehensive knowledge of quality and GMP principles and maintains current understanding of global GMP drug manufacturing regulationsBA/BS degree in Science related field or manufacturing is highly preferred, however, strong experience in Quality Assurance in a regulated industry may be considered in absence of a 4 year degree5 plus years experience as a Quality Professional requiredPI3f06bd20dbd2-7470
Not specified in the original listing.
Not specified in the original listing.
Olon USA LLC is a company involved in the pharmaceutical industry, focusing on analytical laboratory services and quality control. The organization emphasizes adherence to good laboratory and manufacturing practices. Read More