As a consultant, you will work with our clients on the following missions:
- Provide QA oversight of commissioning, qualification and validation activities to GMP manufacturing facility.
- Hands on experience with Validation methodology (FAT, SAT, IQ OQ, PQ)
- Responsible for managing the review/approval of design and commissioning documentation, validation protocols, reports and support records to certify compliance with specifications and procedures.
- Review and assist in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods and laboratory instruments.
- Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method and computer system validation.
- Responsible for supporting internal and external inspections for Quality Assurance Validation.
- Must have strong understanding of Computerized and Automated Systems Validation Engineering lifecycle.
- Bachelor’s Degree in Science or related technical field.
- Minimum of 2+ years of Quality Assurance/Validation experience in pharmaceutical industry.
- Experience in IT systems, automation, operations and manufacturing within the pharmaceutical industry and in new manufacturing facility start-up environments is required.
- Must have demonstrated understanding of cGMP.Strong understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations is required.