Associate Manager

Job Description

SYNGENE QA JOB DESCRIPTION Responsibilities : You are responsible for the following activities: Sl. No. JOB RESPONSIBILITIES
Responsibility Summary: Responsible for handling analytical QA activities related to Quality Control Microbiology.
Primary Responsibilities: Review and approve Analytical QA activities related to Quality Control Microbiology .
• Responsible for identifying and implementing necessary changes to develop a vision for the efficient functioning of the quality assurance function.
• Responsible for taking appropriate decisions whenever necessary without affecting quality and GMP aspects.
• Ensuring that the quality assurance aspects are completed appropriately and timely, including auditing, trend analysis, complaint review, and document review, maintaining compliance with clients and other regulations.
• Responsible for communicating quality aspects to clients effectively whenever necessary.
• Handling of customer projects and ensuring the documents related to Quality Control Microbiology are appropriately reviewed and approved.
• Assist QC department in developing appropriate corrective & preventive actions.
• Review of root cause investigations and subsequent CAPA to ensure and align with the quality system and regulatory compliance.
• Review and approval documents related to CSVC & overall qualification activity, protocols, reports, etc.
• Review and approve documents related to Qualification of systems, instruments, equipment, etc., generated by QC Microbiology and crosslinked departments.
• Review and approve Analytical Method validation, Analytical method transfer, Excel validations, Forced degradations, LIMS - protocols, and reports.
• Being a part of the investigations. Review and approve deviations, Laboratory incidents, Out of calibrations, Out of specifications, CAPA, and Out of trend.
• Issuance of Documents (Annexures, ODS, Calibration sheets, Log sheets, etc.)
• Review and approval of deviations, Laboratory incidents coordinating in identifying the root cause investigations with CAPA approval.
• Responsible for handling, evaluating, and approving change control & adequate closure.
• Review & approval of specifications.
• Review and approve, SOP s, protocols, Instrument operating procedures, IQ/OQ/PQ/DQ of all instruments of QC Microbiology.
• Be a part of self-inspection & conduct regular GMP rounds in the Quality Control Microbiology & Quality control biologics laboratory.
• Coordinating with the laboratory personnel in the handling of the customer queries
• Review of all the documents for adequacy concerning the principles of ALCOA+.
Secondary Responsibilities:
• Ensure new and existing personnel are adequately trained in the proper performance of their assigned tasks
• Responsible for contributing a positive attitude and inspiring others toward continuous quality improvement.
• Ensure personnel s of AQA are adequately trained on the quality system regulations and quality policies
• Directing QC and cross-functional team in evaluating the effectiveness of corrective actions related to QMS and participation in other projects as assigned
Reason for Revision: Designation change NOTE :
1. First version of the JD shall be considered as version 001. Every subsequent change shall be numbered in sequentially increasing order (i.e., 002, 003 etc.)
2. As and when the need arises, your Job responsibility will be amended by your reporting Authority.
3. Whenever a particular designate is absent, the responsibility is delegated upwards even though the job function may be carried out by the next lower level.
4. The effective date of Job description shall be the date of approval by HOD/ Reporting manager.
Name: HOD/Reporting Manager _ ______________________________ (Signature & Date) I, hereby declare that the above listed responsibilities assigned to me are read and understood. Employee : _________________________ (Signature & Date) Effective Date: __________________________ (To be filled by HOD/Reporting Manager) ,

Keyskills :
salesmanagementmiscustomer relationsqualityanalytical method validationroot causetrend analysischange controlquality systemquality controldocument reviewmethod transfer