Team Leader - GLP QA
Aurigene Pharmaceutical Services Limited
Date: 3 weeks ago
City: Hyderabad, Telangana
Contract type: Full time
Role: Lead GLP QA
Te chnical Responsibilities
Responsibilities Include But Are Not Limited To
Te chnical Responsibilities
Responsibilities Include But Are Not Limited To
- Leadership and oversight to the overall Quality Assurance (QA) function to support OECD GLP compliance at Hyderabad site of Aurigene Pharmaceutical Services Ltd., Regulatory submission studies conducted at Aurigene Pharmaceutical Services Ltd .
- Assure Test Facility Management, compliance to OECD Principles of GLP and terms and conditions of National GLP Compliance Monitoring Authority with respect to GLP functions.
- Serve as a host/escort during compliance monitoring/regulatory inspections.
- Coordinate and host Sponsor audits.
- Prepare, Review Standard Operating Procedure(s) to describe procedures related to Quality Assurance, Management and General SOPs as applicable in compliance with principles of GLP.
- Review and assignment of action plans for the change control management and approval as defined in the SOP.
- Review Risk Assessment procedure is adequate and comply with the SOP requirement.
- Review and Approval of SAP Schedules of Calibration and Preventive Maintenance and Task lists of relevant instrument/equipment.
- To approve the PM Schedules of IT systems.
- Review SOPs (QA Review) for clarity, consistency and adequacy to support applicable regulatory requirements specific to system compliance. Periodically review SOPs to ensure adherence to changing regulatory requirements.
- Compile from multiple stakeholders into a single document and review Master Schedule for accuracy and completeness with respect to GLP studies. Compile MS into a single document once a year and archive.
- In conjunction with assigned QA auditors, assure the TFM, the GLP study audit standard meets regulatory requirements and not limited to:
- Verify study plan for clarity, internal consistency, applicable SOPs, regulatory guidance and OECD Principles of GLP.
- Identify critical phases of a GLP study for in-process (in-life) audit in conjunction with the Study Director.
- Review study reports to ensure that they accurately reflect the raw data generated during the study and contain everything as per OECD Principles of GLP.
- Review computerized systems used to generate study data.
- Issue QA statement to GLP study after Study Director has signed the GLP Compliance Statement.
- In conjunction with assigned QA auditors, assure the TFM has approved Annual Facility Audit Calendar’ and is adhered to.
- Ensure all study and facility audit observations are followed up to completion. Appraise TFM of all audit observations.
- Assure TFM of the consistency and compliance to study plans/protocols in all GLP and Regulatory submission studies.
- Provide periodic QA reports to TFM.
- Discuss with all the stakeholders for overall quality improvement for the test facility and seek guidance and approval from TFM for its implementation.
- Maintain an Annual Facility Audit Calendar approved by Management in the beginning of every fiscal year to assure the facility is fit for purpose and documents to support processes are in place.
- Assure proper and complete resolution of findings/non-compliant situations in a timely manner, including approval of corrective action/preventive action (CAPA) plans, as necessary.
- Ensure timely archival of records pertaining to quality systems such as and not limited to audit reports pertaining to study and facility, training records of ex-employees, master copies of SOPs etc.
- Audit Contract Research Organizations (CRO) and vendor qualification audits as assigned by the TFM.
- Deliver training in the basic principles of GLP to new staff within the organization as well as training for staff taking on GLP roles (for example, Study Directors). Conduct periodic refresher trainings within the test facility.
- Prepare documents for re-certification and surveillance inspection and submit as per directions from NGCMA. Prepare an Action Taken Report in consultation with all respective stakeholders to address NGCMA audit observations, ensure corrective actions are completed and preventive measures are taken to avoid recurrence of such incidents. Submit ATR to NGCMA within stipulated timelines.
- Prioritize workloads within the department
- Administrative Responsibilities
- Manage QA staff in accordance with organizational policies and practices. Responsibilities include planning, assigning and directing work, appraising performance and guidance in professional development.
- Ensure that staff has adequate training, resources, system access to complete job responsibilities.
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