QC Micro Analyst

at  Piramal Pharma Solutions

Key Roles/Responsibilities:

• Microbiological testing of raw materials, in process, bulk drug substance, final products and stability products to GMP and in accordance with Annex 11 Computerised Systems and 21CFR part11 Good Documentation Practices for Electronic Data
• Conduct Environmental Monitoring and associated Identification of isolated micro-organisms.
• System owners of QC equipment, assisting in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Quality Control department.
• Ownership and accountability of deviations, investigations and laboratory investigations and timely completion of these documents
• Preparation and update of SOPs, instructions and protocols and other Quality Control documentation
• Checking and reviewing of data in compliance with Data Integrity requirements
• Actively contribute to department and site audit readiness requirements including any continuous improvement initiatives.
• Calibration of equipment and instruments used to perform QC testing and informing relevant personnel in a timely manner of any failure of calibration
• Maintain Quality Control information systems
• Maintain a technical ability, knowledge and understanding of relevant regulatory requirements for GMP, safety and environmental policies required in order to perform role as QC Micro Analyst
• Assist in investigation of quality incidents and other problem solving forums and complete QMS documentation in a timely manner.
• Attend internal and external scientific and technical meetings and conferences where appropriate
• Available to provide cover for other departments within the organisation
• Available to undertake any other duties as requested by the line manager in accordance with Company requirements

Competencies:

• Attention to detail
• Reliability
• Effective communication
• Understanding of scientific and technical processes

• Microbiological testing of raw materials, in process, bulk drug substance, final products and stability products to GMP and in accordance with Annex 11 Computerised Systems and 21CFR part11 Good Documentation Practices for Electronic Data
• Conduct Environmental Monitoring and associated Identification of isolated micro-organisms.
• System owners of QC equipment, assisting in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Quality Control department.
• Ownership and accountability of deviations, investigations and laboratory investigations and timely completion of these documents
• Preparation and update of SOPs, instructions and protocols and other Quality Control documentation
• Checking and reviewing of data in compliance with Data Integrity requirements
• Actively contribute to department and site audit readiness requirements including any continuous improvement initiatives.
• Calibration of equipment and instruments used to perform QC testing and informing relevant personnel in a timely manner of any failure of calibration
• Maintain Quality Control information systems
• Maintain a technical ability, knowledge and understanding of relevant regulatory requirements for GMP, safety and environmental policies required in order to perform role as QC Micro Analyst
• Assist in investigation of quality incidents and other problem solving forums and complete QMS documentation in a timely manner.
• Attend internal and external scientific and technical meetings and conferences where appropriate
• Available to provide cover for other departments within the organisation
• Available to undertake any other duties as requested by the line manager in accordance with Company requirement