General
Ensure adherence to GMP regulatory requirements by one and all in the facility.
Preparation, Review and updating of standard operating procedures associated with Market Complaints and Supplier Qualification Management.
Initiation of change controls, CAPA and deviation related to Market complaints, Supplier qualification, Nitrosamine impurities ang Artwork management.
Routine monitoring of all functional area to ensure adherence to the SOPs
Coordination for harmonization of Global Policies and Procedures across Apotex Inc, Canada
Perform Gap assessment of GPOL s and GSOP s against site SOP s and ensure site implementations
Responsible to perform the GMP rounds (Adhoc/verifications) within ARPL to ensure/sustain the state of compliance
Market complaints:
Logging, investigation of Market Complaints and initiate necessary CAPA
Preparation of complaint trending report
Review of SME complaint investigation reports.
Supplier qualification:
Review of Suppliers and Material related documents for new material introduction to ARPL
Review of qualification documents of the third-party suppliers of API, excipient, packaging materials and contract testing laboratories
Preparation and Maintenance of third-party audit schedule and status.
Coordination and Support for internal/ regulatory audits and ensuring compliance to Regulatory guidelines.
Risk assessment of Excipients as per European Union guideline
Co-ordination and Management of Supplier Notification and Com Alerts.
Review of quality agreement related to raw material manufacturer, packaging material manufacturer and service providers. Management of quality agreement schedule.
Nitrosamine assessment:
Review of Nitrosamine risk assessment report.
Coordinate for Nitrosamine Control Program
Artwork Management:
Review of commercial printed packaging material Artworks
Lead/Approve the deviation, LIR mfg. investigations, CAPA, temporary change records:
Lead & approve the deviation investigation and identify/approve the associated CAPAs
Review of cognition load assessment in case of Human error.
To ensure the implementation of CAPA actions as proposed.
Review & approve the manufacturing assessments relevant to LIR (OOS/OOT).
Review & approve the temporary change records with proper risk assessment.
Sufficient verbal & written communication
Co-ordination with CFT to manage and complete the task within stipulated time.
Prepare the trend records for deviation, CAPA & temporary change.
Monitor the timelines, overdue and non-moving records.
Monitor the effectiveness checks of CAPAs:
Review & monitor the effectiveness check of implemented CAPA actions as per monitoring frequency. Handling of effectiveness failure of CAPA.
Handling of Change control management system:
Review & approve the change control with adequate information.
Ensure all the assessments are written properly and adequate as per procedure.
Monitor the timelines, overdue and non-moving records.
Monitor the training compliance at QA function:
Tracking for on-time completion of induction and annual training on GMP courses to employees.
Preparation of Annual GMP training calendar, list of Qualified trainer and list of training co-ordinator.
Ensure the training completion criteria and implementation of SOPs/ document.
Expert hand on training related Software (GLMS, TMA etc.)
Internal and External Audits:
Internal and External Audit management
