This position is responsible for directing and supervising a group of employees, involving planning, executing and monitoring quality assurance. Monitor procedures with regard to systems and operations to assure that corporate Quality Assurance standards and government regulations are achieved. Develops, implements, and coordinates product assurance programs to prevent or eliminate defects in new or existing products.
Lead the Technology Transfer from R&D to manufacturing for new and existing products
Lead process validation/verification, cleaning validation/verification and equipment, utility and facility qualification study
Reviewing process validation plan, cleaning validation plan
Review/Approve process validation/verification, cleaning validation/verification protocols
Resolve all deviations/discrepancies encountered during protocols execution
Provide guidance on product failure investigations
Provide technical review of Change Requests (both internal and external) and recommendations
Define critical process parameters, specifications, requirements, challenges, and activities to be included in process validation/verification, cleaning process validation/verification, and equipment performance qualification studies
Perform general systems audits of those procedures, operations and practices that directly impact the safety, quality, strength, integrity, and purity of drug products.
Provide assurance to management that facilities, equipment, personnel, methods, records, controls, validations, procedures and practices are in conformance with all applicable regulations.
Investigations exceeding specified SOP completion period, documentation of justifiable investigation extension requests and approval, frequent changes to a process, product and raw material rejections.
Collect and maintain validation, verification, and qualification information in a supporting reference database and keep updated on the current knowledge and perspectives on validation within the industry
Requires knowledge about 21 CFR, cGMP, FDA and ICH guidelines, strong knowledge about pharmaceutical industrial guidelines. Knowledge of general principle and practice for process validation, cleaning validation and equipment and facility qualification. Knowledge of state and federal employment laws relating to key areas of responsibility.
Requires strong leadership, interpersonal, analysis, and reporting skills. Basic statistical skill, data interpretations and compilation. Good computer and technical skill, problem solving and decision making. Intermediate MS office, communication and presentation skills.
Strong abilities to motivate subordinate, team management, resource planning and utilization. Ability to plan and complete the tasks in predefined time line, ability to develop interdepartmental relationships.
This job requires minimum ten years of cGMP experience in the pharmaceutical validation, qualification, preferably within the research and development or technology transfer within the pharmaceutical manufacturing environment.
Education, experience, knowledge and abilities normally required for competent performance in the job.
Minimum BS/BA and/or MS and/or PhD degree in any life sciences field (Pharmaceutical, Biology, Microbiology, Chemistry, Biochemistry, Physics, Engineering, etc.) preferred. Specific background and experience may be substituted for the degree requirement.