Manager of Quality Assurance Validation
Summary
The role of the QA Validation Manager is to ensure compliance with company and regulatory requirements e.g. Good Manufacturing Practices (GMP), Code of Federal Regulations (CFR) and local regulations. The QA Validation Manager, directly reporting to the Quality Director, manages the QA Validation Specialists, coordinates and schedules all activities to assure that all new or existing pieces of equipment, utilities, instruments, analytical methods and processes are adequately qualified and validated in accordance with the requirements outlined in the approved Validation Master Plan requirements, the approved validation test protocol, applicable policies and procedures, through review of the aforementioned documentation and collaboration with the responsible party.
Responsibilities and Tasks
•Manage the QA Validation Compliance function at site, including all validation activities related to Critical Utilities, Equipment, Analytical Instruments, Analytical Methods, Cleaning, Process, and Computer Systems.
•Perform Quality review of validation master plans, qualification protocols (DQ/IQ/OQ/PQ), and final reports.
•Review all equipment and process change control document; perform Risk Assessment to determine criticality of the proposed changes.
•Write, review, and revise validation SOPs compliant with site procedures and corporate policies.
•Interact with other departments and other SUN sites regarding validation and qualification.
•Provide QA oversight and/or review during the validation process.
•Support the Validation Team in evaluating all the necessary tests needed to qualify critical equipment, utilities, and processes.
•Perform compliance reviews of Validation Protocols and Final Reports in support of validation efforts.
•Perform compliance reviews of change control requests. Attend Change Control Review Board meetings as required.
•Perform compliance reviews of all applicable Deviations, Investigations, and CAPAs related to qualification and validation.
•Perform internal audits of the qualification and validation processes, as required and write final audit reports summarizing observations.
•Track all open audit observations to assure prompt closure.
•Review and approve investigations pertaining to calibration issues. Review and oversee execution FAT, SAT, and Commissioning of Equipment.
•Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies. Knowledge
Requirements:
Skills and Abilities
•Solid knowledge of qualification/validation principals and their practical applications.
•Attention to detail, good verbal and writing skills.
•Proficient in the use of Microsoft Word, Excel, Access, PowerPoint and Explorer.
•Ability to work well with others and is a team player.
•Ability to pay attention to detail and to work independently, outstanding organizational, interpersonal and analytical skills, excellent verbal and written communication skills required.
•Familiarity with regulatory/compliance environment (cGMP, USP, EP, ISPE, PDA, and ICH) associated with aseptic parenteral drug manufacturing.
•Thorough, detail-oriented, have the ability to multi-task and possess strong organizational and communication skills. Experience in the start-up and validation of a cGMP facility for FDA approval plus knowledge of facilities, equipment, and critical utilities supporting the qualification of a pharmaceutical manufacturing facility. Education and Experience
•BS in a scientific discipline or equivalent.
•Experience in a regulated industry preferred.
•A minimum of 5-8 years experience in a Pharmaceutical /drug (FDA regulated) industry
•Experience in Pharmaceutical manufacturing environment
•Experience in validation protocol review for equipment, process, and methods and experience in risk management preferred
•Working knowledge of cGMPs, ICH Guidance Documents
•Sound knowledge in a GMP Regulated environment, solid experience in GMP auditing Physical Requirements
•Stand, walk, sit, use hands and fingers to handle or feel, talk or hear, stoop, kneel, crouch or crawl
•Close vision.
•Gowning, Safety glasses, and gloves
•Lift up to 50 lbs.
•Some travel outside of work facility may be required Environmental Conditions
•Laboratory, warehouse and office areas
•Exposed to noise, hazardous material (chemical, biological and radiological).
•Exposure to radiation within NRC limits.
•Requires protective clothing in lab areas such as lab coat, safety glasses, gloves and particulate protection.
•Radiation detection badge Annual Radiation Safety Training Required. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity and/or expression, national origin, protected veteran status, disability, genetics, or citizenship status (when otherwise legally authorized to work) and will not be discriminated against on the basis of such characteristics or any other status protected by the laws or regulations in the locations where we operate. We encourage applicants of all ages.
