Executive QA Validation

Description:

• Prepare and review qualification protocols and reports for equipment, utilities, and systems (DQ, IQ, OQ, PQ, as applicable). 

• Coordinate and monitor qualification activities with Engineering, Production, and Validation teams. 

• Ensure qualification documentation complies with GMP and regulatory requirements. Maintain qualification schedules and ensure periodic requalification is completed on time.

• Conduct quality risk assessments using tools such as FMEA, HACCP, or risk matrices. 
• Identify potential quality risks and recommend appropriate mitigation strategies. 

• Ensure risk management documentation is maintained and periodically reviewed.

• Draft, review, revise, and maintain Standard Operating Procedures (SOPs), work instructions, protocols, and quality documents. 

• Ensure document control procedures are followed throughout the document lifecycle. 

• Coordinate periodic review of controlled documents.

• Provide training on new or revised SOPs and maintain training records.

• Identify opportunities for process improvement and quality enhancement. 
• Support implementation of quality metrics and trend analysis. 

• Participate in cross-functional quality improvement projects.

• Develop and review process validation protocols, reports, and validation master plans. 
• Coordinate execution of process validation activities with cross-functional teams. 
• Evaluate validation data and ensure processes consistently meet predefined acceptance criteria. 

• Support cleaning validation, analytical method validation, and computerized system validation where applicable.

Additional Skills :

• Knowledge of GAMP 5 and 21 CFR Part 11.
• Strong Understanding of ALCOA+ principles.
• Performing risk assessments using tools like FMEA, HACCP, and risk matrices.
• Hands-on experience with IQ, OQ, PQ, and requalification of manufacturing and laboratory equipment.
• Strong Project Management Skills