| Job Description | REPORT TO: Validation Manager
SUPERVISES/DIRECTS: N/A
POSITION SUMMARY:
Report direct to the validation manager. Responsibilities include designing, and implementing manufacturing validation programs, and ensuring that all GMP requirements are satisfied.
PRINCIPAL DUTIES:
Develop validation protocols in compliance with IQ/OQ/PQ requirements and industry guidelines as related to quality control/assurance manufacturing activities.
Design and implement various protocols to validate and monitor the various quality control/assurance manufacturing activities or systems, such as, WFI, air handling, etc., in compliance with cGMP and industry guidelines.
Ability to validate, calibrate, maintain and trouble-shoot various equipment as required for all quality control/assurance activities.
Perform various quality control/assurance duties and initiate appropriate documentation as required.
Written and oral skills at a level commensurate for interaction with staff, vendors and clients as necessary.
Perform Risk-Based Analysis and validate various Part 11 Systems.
Implement and validate various control systems.
Plan, design, and coordinate development project activities.
Perform other related duties and responsibilities as assigned.
MINIMUM QUALIFICATIONS/REQUIREMENTS:
Bachelor’s or Master’s degree in engineering, chemistry, biology, or related scientific discipline and a minimum of three (3) years experience in the same or closely related GMP environment.
Demonstrated competence in related Mfg. protocols and validation procedures.
Oral and written communication skill must be at a level appropriate for effective in-house communications and report preparation. |
| | Company | | PYRAMID Laboratories, Inc., | Job Code | | State or Province | | California | | |
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