QC Validation Engineer Fenton, Missouri
Job Ref: 36428
Relocation Assistance Available
Quality Assurance Validation Specialist
Department: Quality Assurance
FLSA Status: Exempt
Function: Interacts with vendors and peers in Manufacturing, Sales, and Finance, and Product Development personnel to optimize systems and procedures. Selects, develops, and evaluates personnel to ensure the efficient operation of the function. Develops and implements key strategic policies and procedures. Provides considerable technical support to the groups of the organization.
Primary Responsibilities and Essential Functions of the Position:
- Prepare, execute, and summarize qualification protocols and related documents (risk management, periodic reviews, URS, FRS, IQ, OQ, PQ, PV, FAT…etc) to support the following:
- Solid Dosage Equipment
- Process Validation
- Re-qualification of existing manufacturing equipment and utilities
- Develop and write quality discrepancies and investigations associated with the validation studies.
- Work closely with manufacturing, laboratory, both QC and R&D, for sample coordination and to ensure required samples are process and tested as required during protocol execution.
- Ensure validation studies of the manufacturing, QC, R&D, and facilities utilities serving the functional areas to ensure all testing equipment is complete to the required cGMP standards.
- Supervise production operators, QC, and R&D analyst during validation studies, as required.
- Prepare change control documentation for validation activates.
- Design maintain and continually improve the validation systems in line with current national and international standards.
- Provide technical expertise and guidance on validation policies and procedures and the implementation of those within QC, manufacturing, and R&D functional areas.
Skills and Abilities Required:
- Good working knowledge of cGMP and regulatory standards for validation.
- Experience in writing & reviewing SOPs and protocols for accuracy, traceability and compliance.
- Minimum 5 years’ experience leading people.
- Experience with GAMP standards.
- Strong communication skills both written and verbal.
- Strong sense of urgency on work related matters.
- Strong organizational skills with high attention to detail.
- Possess excellent computer (MS office: word; excel; access; outlook), writing and editing skills.
Minimum Education and Experience Required:
- Bachelor of Science
- Minimum 3 years’ experience in performing and leading validation studies within the pharmaceutical industry.
- While performing the duties of this job, the employee is regularly required to, stand, sit; use hands and fingers to operate a computer and telephone keyboard reach. Ability to lift up to 35 pounds daily.