Quality Assurance Analyst

Description: Support QA in providing QA oversight to GMP product development and manufacturing activities, material and product release and stability testing. Provide support in the review and approval of cGMP documentation, including, but not limited to: specifications, standard operating procedures/ test methods, batch records, protocols, certificates of analysis, analytical reports, method validation/transfer reports, deviations/investigations, and training files. Maintenance of electronic QMS for document, CAPA, Quality Event, Complaint, and Audit handling. Administration and maintenance of electronic Training Management System. Facilitate GMP and QA introductory training for new employees. Provide support in the review and approval of investigations, unexplained discrepancies, failures, and out-of-specification results. Support internal and external inspections and audits. Support QA in response to customer & regulatory agency inspection findings. Provide support to 3rd party audits at LIR site. Support internal or external transfer of analytical methods and R&D projects to other Lupin sites. Create Quality Metrics and provide presentations for Management Reporting purposes. Inspection and sampling of incoming materials for release and GMP area prior to manufacturing activities. Facilitate quality-related training and mentoring, where required. Support the Annual Product Review process Partnership with other functional areas (Operations, Product Development, Quality Control, Engineering and Facilities, Manufacturing, Regulatory Affairs, and Supply Chain) to ensure site continuous compliance. Support supplier qualification process and review of quality agreements Review of equipment/software qualification and validation documentation and supporting records Issuance of GMP documents i.e. logbooks, notebooks, batch records, etc. Management of QA retain samples and archival of GMP documentsSkills:capa, gmp, audit support, Audit, InspectionAdditional Skills & Qualifications: A Bachelor’s Degree (B.S.) in Chemistry, Biology, Microbiology or Pharmacy related field. A thorough knowledge of cGMP regulations as they apply to Drugs and Medical Devices is required. Experience with Respiratory Product development is preferred. Relevant experience with laboratory and manufacturing functions along with GMP quality assurance functions is required. Experience in laboratory practices, release of starting materials and finished products, conducting investigations, as well as, internal and external audits. Ability to work and make decisions independently and on multiple projects, flexibility to adapt to changing priorities. Ability to handle internal resistance and enforce adherence to internal quality policies and the cGMPs. Ability to interface and work with a diverse group of departments and individuals is required. Must be team oriented with excellent interpersonal skills. Must have the ability to express regulatory requirements clearly and understandably.Experience Level:Entry LevelAbout Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.