Website Aequor Technologies LLC
Aequor Technologies LLC
Company : Aequor Technologies LLC
Duties
Independent drafting and execution of complex validation plans, protocols, and test strategies to ensure compliance and expedited release of critical site equipment. Candidate is considered and experienced professional requiring minimal assistance from more experienced colleagues. The candidate is balancing their own competing priorities while helping ensure that work generated globally is conducted per regulatory requirements and company procedures.
Serve on assigned internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality related issues and/or support continuous improvement.
Train personnel in quality and validation principals
Support, Engineering and departments in the selection, review, acquisition, and upgrade of systems and production equipment. Provide technical support in developing user and functional requirements specifications, URS, RA FRS and DQ for systems and equipment.
Serve as Lead Validation representative on assigned project teams and communicate new requirements/perform training with Validation team to assure all timelines are met resulting in successful project completion and new product launches.
Utilize industry experience and knowledge to support Production and Engineering. Share quality philosophies throughout Operations
Utilize industry experience, knowledge and procedures to support Engineering and Production
Performs all company business in accordance with all regulations (e.g. EEO, FDA, etc.) and Company policy and procedures. Demonstrated high ethical and professional standards with all business contacts in order to maintain BIAH's reputation in the community. When violations are noted or observed, they are immediately reported to management.
Successfully completes annual training on Compliance Modules as assigned by the Company.
Training completion is monitored on monthly basis through KPI reporting to Quality management.
Routine qualification execution includes:
Equipment ,facilities, utilities, computer systems qualification for complex biopharmaceutical production equipment.
Room Qualification and Smoke studies in grade A pharmaceutical facilities
Media fill qualifications oversight and support
Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers and warehouse areas.
Extensive experience with Ellab data loggers and software
Extensive technical writing experience to independently write and execute protocols and complete final reports (minimal oversight from validation reviewer)
Comprehensive knowledge and understanding of cleaning validation concepts and principles.
Comprehensive knowledge and understanding pharma grade utilities ( water HVAC, gases)
Support Maintenance, Engineering and Production Depts. in the selection, review, acquisition, and upgrade of systems and production equipment.
Provide technical support in developing user and functional requirements specifications, URS, RA, FRS, and DQ for systems and equipment.
Develops and assists with audit responses and completion of assigned CAPAs by target due dates. Included is the responsibility for making sure Validation areas are "inspection ready" at all times.
Execute all actions required to support Change Control, Deviation and CAPA on-time closure
6 years GMP validation or similar experience in a GMP manufacturing or similar production environment
Minimum of 10 years GMP validation experience in a GMP or regulated manufacturing or similar environment in lieu of a degrees.
Experience must be inclusive of at least 3 years leading projects.
Ability to plan, schedule, organize, prioritize and coordinate project activities.
Ability to function in a leadership role and within cross function teams.
Ability to analyze validation and production data to assess compliance with GMP requirements and/or troubleshoot compliance problems
Excellent written and verbal communication skills
Excellence in comprehension/application of FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles
Strong theoretical and practical knowledge of regulated processes and one technical discipline, such as biology to apply knowledge or experience to assigned tasks.
Ability to make decisions regarding the acceptability of product based on documentation provided.
Demonstrated ability to work with diverse groups of people and conflict management.
Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook, PowerPoint).
Bachelors , preferably in a science or engineering related field