QA Validation - ProPharma Group : Job Details

Responsibilities:

Primarily responsible for providing QA oversight for the qualification of Equipment, Facilities, Utilities, Analytical Instruments and Computerized Systems, including:

• Supporting qualification and startup activities for large capital project as a Quality Assurance resource,

• Provide QA review and approval of system lifecycle documentation (Requirements Specifications, Configuration Specification, Risk Assessments, IQ/OQ/PQ Protocols, Summary Reports) for equipment, facilities, utilities, computerized systems and analytical instruments,

• Perform QA review and approval of validation non-conformances,

• Assist in the resolution of compliance issues in partnership with process owners and SMEs.

• Provide QA support for any other project related activities as necessary.

Experience:

• Bachelors Degree in Engineering or Life Sciences,

• Minimum of 7 years of total combined experience in quality assurance and/or validation within a GMP regulated manufacturing environment (FDA, EMA, MHRA),

• Some experience in biologics and/or gene therapy manufacturing facilities,

• Must have experience providing QA oversight of qualification of equipment, utilities, facilities, and analytical instrumentation and computerized systems,

• Experience with large capital project and facility startup is desirable,

• Experience with QC analytical systems is desirable,

• Must be knowledgeable of current industry practices and regulatory expectations regarding qualification and validation, as well as data integrity requirements for computerized systems,

• Must have ability to communicate effectively with a wide range of personnel and cross-functional teams,

• Must have capability and desire to perform detailed review of GMP documents,

• Experience working with eVLMS, eDMS and CMMS

Contract opportunity; 12+ months in duration; primarily onsite in Philadelphia Area.