Quality Assurance Representative

at  Morgan McKinley

Key Responsibilities:

• Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents.
• Review and approval of change controls, observations/ deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches.
• Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data, sampling protocols and Annual Product Reviews.
• Re-identification, re-evaluation & disposition of raw materials, intermediates and packaging components used in the manufacture of relevant pharmaceutical products where necessary.
• Batch disposition, including approval of batch records, for API and Intermediate batches & approval of CoA’s.
• Evaluation and contribution of regulatory information to regulatory documents
• Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence the area of responsibility
• Participation in the Site Self-Inspection program and audit of production, systems and service areas for compliance with Product Quality Systems, policies, guidelines and procedures.
• Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.

EDUCATIONAL REQUIREMENTS

• BSc, MSc, or PhD in Chemistry, Engineering or related discipline, with minimum 1 year production/relevant experience.

Key Responsibilities:

• Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents.
• Review and approval of change controls, observations/ deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches.
• Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data, sampling protocols and Annual Product Reviews.
• Re-identification, re-evaluation & disposition of raw materials, intermediates and packaging components used in the manufacture of relevant pharmaceutical products where necessary.
• Batch disposition, including approval of batch records, for API and Intermediate batches & approval of CoA’s.
• Evaluation and contribution of regulatory information to regulatory documents
• Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence the area of responsibility
• Participation in the Site Self-Inspection program and audit of production, systems and service areas for compliance with Product Quality Systems, policies, guidelines and procedures.
• Reports and escalates critical quality issues to the appropriate level of quality management for final resolution