The Process Validation Engineer – OTC Drug and Device Products (PVE) shall provide a facility Validation Master Plan to address requirements for roles and responsibilities, facility overview and design, general validation and qualification approach, facility Heating, Air Conditioning, and Ventilation (HVAC), utilities (including the water system and compressed air), manufacturing and laboratory equipment, computer systems (basic overview), products and manufacturing processes, cleaning, and analytical methods. A Quality Systems approach shall be applied to the Validation Master Plan to ensure the above requirements are addressed for all manufactured products (OTC drug and device).
Based on the requirements specified in the facility Validation Master Plan, the PVE shall generate and execute Process Qualification protocols for all OTC drug and device products (30 to 50 formulations), applying a matrix approach. In support of Process Qualification, the PVE shall update batch records for all OTC drug and device products to reflect current requirements for monitoring critical process variables. Updated batch records shall be utilized for Process Qualification activities. After completion of Process Qualification activities, the PVE shall generate Process Qualification reports for all OTC drug and device products. As required, the PVE shall also update facility procedures relating to the requirements for ongoing qualification/requalification of OTC drug and device products.
Essential Duties and Responsibilities
- Ensures that the facility Validation Master Plan, Process Qualification Protocols/Reports comply with United States Food & Drug Administration, Health Canada, ISO, and alternate regulatory and/or notified body requirements per client request.
- Ensures target dates associated with completion of the Validation Master Plan, Process Qualification Protocols/Reports, batch records, and procedure updates are met.
- Responds to comments/inquiries provided by SQA management and client with respect to in process Validation Master Plan, Process Qualification Protocols and Reports, batch records and procedures and executes revisions, as required.
- Responsible for following all SQA requirements related to travel arrangements, submission of work/travel hours, and expense report management.
- Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings (as appropriate).
Qualifications Education and/or Experience
- A Bachelor of Science or an advanced degree in a related field of study and 10 or more years of related experience and training.
- Experience interacting with United States Food & Drug Administration and alternate regulatory and/or notified bodies as required.
- Knowledge and skills associated with generation and execution of Validation Master Plans, Process Qualification, batch record generation and execution, and procedure generation/revision.
- Experience leading Process Qualification activities is required.
- Understanding of Data Integrity and Computer System Validation requirements.
- Experience with and understanding of the following regulations and standards: 21 CFR Part 11, 21 CFR Part 210/211, 21 CFR 820, ISO 9001, ISO 13485, ISO 14971, ICH Q9, and ICH Q10.
Other Skills and Abilities
- Ability to read, analyze and interpret applicable guidances, regulations and standards.
- Ability to respond to complex inquiries from SQA management or clients. Ability to effectively present information to SQA management or clients.
If interested in this position , please contact Tami Parker at email@example.com or call to 310-802-4415