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Form of workJob Description
Responsibilities:
- Review qualification requirements for any new instrument, equipment and process with system owner and cross-functional teams.
- Prepare protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, and cleaning validations. Preparation and review of associated procedures, change controls, standard operating procedures, validation master plans, etc.
- Execute protocols and related activities associated with validating equipment/ systems/ utilities/ processes, transferring new products/ processes from R&D to manufacturing, and executing process/documentation improvements. Perform statistical analysis for process monitoring.
- Initiate and investigate protocol deviations, events, exceptions, and coordinate follow up with QA.
- Initiate, follow-up, close out and implementation of corrective and preventive actions.
- Co-ordinate activities related to risk management and preparation of quality risk management and risk assessments related to but not limited to instruments, equipment, products, and processes.
- Coordinate with cross functional teams for internal and external audits. Provide all required documentation.
- Perform other duties as assigned.
- Bachelor's degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
- Analytical – Working knowledge of cGMPs and internal SOPs; identifies, collects, and organizes data from multiple sources; ability to handle several projects simultaneously; demonstrates attention to detail; identifies and resolves problems in a timely manner.
- Technical Skills – Mechanically inclined; reads and interprets process documents and validation protocols; follows operating instructions; and good computer skills; ability to make timely decisions, Assist Manufacturing management/QA management in performing root cause analysis.
- Ability to read, write and interpret documents such as Site Master Plans, Validation Master Plans, Validation protocols, Technology Transfer Documents, Master Production Records, Operating and Maintenance Instructions, and procedures manuals.
- A background in cGMP compliance within the pharmaceutical, biologics, or medical device manufacturing industry
