Responsibilities:
- Develop and maintain oversight of the Manufacturing Quality Management System (QMS). The company’s QMS is based on FDA guidance and regulations and other applicable standards (i.e., ICH Q7, ISO 14644, USP, etc.).
- Apply quality assurance processes and procedures to ensure product quality and regulatory compliance with applicable API and clinical drug manufacturing guidance, 21 CFR Part 210 and 211 and related regulations and regulatory guidance.
- Develop Analytical and Radioanalytical methods and validations. Create standard operating procedures (SOPs) for QC release testing of radioisotopes as APIs and radiopharmaceuticals.
- Document control oversight which includes working with Lab Information Management System (LIMS)/electronic QMS.
- Write, review, approve and implement QA and QC procedures, specifications, processes, and methods.
- Review individual batch records and documents associated with the program for completeness, errors and omissions.
- Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all meet required specifications.
- Properly train and qualify all designated personnel and confirm all training is documented.
- Conduct periodic facility audits to monitor compliance with established procedures and practices.
- Liaise with internal and external inspectors and representatives, particularly on quality assurance and quality control related topics.
- Oversee the equipment and metrology program (i.e., equipment, personnel qualifications, validations, etc.)
- Ensure analytical equipment is appropriately maintained and calibrated.
- Launch investigation, when appropriate. Initiate, document, and ensure corrective actions are taken to prevent the recurrence of the problem (CAPA, Deviations, OOS). Take action to document and justify deviations from standard procedures.
- Review of trends (e.g., environmental monitoring, deviations, facility issues) to initiate corrective and preventive actions and/or for continuous improvement.
- Continuous review of aseptic operations to ensure compliance to internal procedures (e.g., gowning, cleaning/sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations.
- Oversee the change control process. Ensure changes in the laboratory are accepted or rejected with documentation.
Qualifications
- Master’s degree in Chemistry or Biochemistry OR Bachelor degree with 5-7 years in a science or technical related field of study
- Proficient knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing and distribution of aseptic products
- Knowledge of USP, FDA and cGMP regulations
- Strong interpersonal and communication skills for interacting with site personnel, inspectors, and internal and external vendors
- Electronic Quality Management System (QMS) experience
- Ability to effectively present information, deliver training and respond to questions from groups of managers, clients, customers and the general public
- Ability to define problems, collect data, establish facts and draw valid conclusions
- Radioisotope or radiopharmaceutical experience is a plus
- Previous experience with HPLC, TLC, GC, gamma or alpha spectroscopy and other analytical techniques, preferred
- Previous experience in handling and work with radioactive materials, preferred