Job Description

Department Details

Role Summary

•Implementation of QMS and GMP regulations in accordance to the regulatory guidelines.
•Preparation and review of standard operating procedures in accordance to the regulatory guidelines.
•Ensure Data Integrity, adherent to policies and its implementation.
•Ensuring Preparation and review of Site Master File, Quality Manual and Organogram.
• Preparation and review APQR of the product under review and to initiate necessary changes based on the final recommendations.
• Document management and control – control of documents (master) and user copies of all master documentation. Labelling and Storage of master documents, validation documents and batch documents. Destruction of documents wherever applicable. Control on IOM, confidential documents and External documents. Issuance and control of batch records. Issuance, retrieval and storage of log-books.
•Responsible for obtaining licenses required for product manufacturing in coordination with regulatory affairs department.
•Responsible for handling Change controls, deviations, risk assessment and CAPA Management.
•Responsible for approval/rejection of change controls, Deviations, CAPA etc.
•Handling of failure investigations, market complaints and product recall and returns.
•Responsible to conduct and coordinate training on quality system procedures and CGMP across the facility. Evaluation of training questionnaires and certification of trainees.
•Review/approval of Trend analysis for quality system parameters
•Conducting Internal Audit as per the schedule and to ensure compliance action plans arising out of noted deficiencies.
•Scheduling, conducting, reviewing and documentation of Management Review Meeting Report.
•Handling of Customer / Regulatory Audits and timely response to the observations
•Responsible for audit compliance and verification of effectiveness of implemented CAPA
•To ensure proper and timely review and approval of all Master documents such as Standard Operating Procedures, Operating Instructions, BMR,BPR, Validation Protocols/reports, Hold time study protocol/reports Stability Protocols, etc.
•Implementation of cGMP and GLP in accordance to USFDA, EU and other global regulatory standards.

Key Responsibilities

Implementation of QMS and GMP regulations in accordance to the regulatory guidelines.
•Preparation and review of standard operating procedures in accordance to the regulatory guidelines.
•Ensure Data Integrity, adherent to policies and its implementation.
•Ensuring Preparation and review of Site Master File, Quality Manual and Organogram.
•Preparation and review APQR of the product under review and to initiate necessary changes based on the final recommendations.
•Document management and control – control of documents (master) and user copies of all master documentation. Labelling and Storage of master documents, validation documents and batch documents. Destruction of documents wherever applicable. Control on IOM, confidential documents and External documents. Issuance and control of batch records. Issuance, retrieval and storage of log-books.
•Responsible for obtaining licenses required for product manufacturing in coordination with regulatory affairs department.
•Responsible for handling Change controls, deviations, risk assessment and CAPA Management.
•Responsible for approval/rejection of change controls, Deviations, CAPA etc.
•Handling of failure investigations, market complaints and product recall and returns.
•Responsible to conduct and coordinate training on quality system procedures and CGMP across the facility. Evaluation of training questionnaires and certification of trainees.
•Review/approval of Trend analysis for quality system parameters
•Conducting Internal Audit as per the schedule and to ensure compliance action plans arising out of noted deficiencies.
•Scheduling, conducting, reviewing and documentation of Management Review Meeting Report.
•Handling of Customer / Regulatory Audits and timely response to the observations
•Responsible for audit compliance and verification of effectiveness of implemented CAPA
•To ensure proper and timely review and approval of all Master documents such as Standard Operating Procedures, Operating Instructions, BMR,BPR, Validation Protocols/reports, Hold time study protocol/reports Stability Protocols, etc.
•Implementation of cGMP and GLP in accordance to USFDA, EU and other global regulatory standards.

Educational Qualifications

Required Education Qualification: M.Pharma
Required Experience: 12 – 18 years