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Form of workJob Description
Technical Services Associate
Duties
Lead and manage Utility, Equipment, and cleaning validation activities at site.
Guide preparation and maintenance of site master validation plan and cleaning validation master plan
Ensure qualification of new and existing equipment. Maintain equipment and utility qualification / re-validation calendar and ensure compliance.
Lead site cleaning validation program: Maintain and update cleaning matrix, ensure new molecules / cleaning processes are always in validated state.
Provide guidance to site calibration program.
Provide technical expertise for evaluation, qualification, and procurement of new equipment / modification of existing equipment and utilities.
Support site in quality and compliance, participate in FDA inspections and lead discussions during audit and inspections on related / relevant topics (e.g. Utility, water system and equipment qualification, cleaning validation etc.)
Actively support site OE initiatives and compliance enhancement activities, with specific emphasis on cleaning practices and procedures
Ensures compliance with all applicable laws, regulatory agency requirements (e.g., FDA, OSHA), corporate policies & standards, and the site procedures.
Metrics reporting to include monthly reviews, CAPA Board and monthly quality metrics
Assist in developing responses and determining CAPA for internal and external audits.
Qualifications
Experience within pharmaceutical laboratory and manufacturing environment.
Experience and knowledge with a variety of root cause analysis tools.
Excellent communication (verbal & written), negotiation, interpersonal, and leadership skills.
Good organization and interpersonal skills.
Excellent problem-solving, decision making, prioritization & trouble-shooting skills.
Demonstrated critical thinking skills with ability to define and investigate problems.
Proficient with use of ERP, LIMS, MS Office and other computer programs, and Statistical Applications.
Education
- High School Diploma
- Bachelor’s Degree in Engineering, Pharmacy or Scientific Field
