Job Description

Designation

Manager-2

Department Name

R&D Quality- GCP QA

List of Responsibilities / Job Functions:

• Conduct audit of Bioanalytical phase of BA/BE studies, which includes in-process audits, retrospective audits etc. Identify gaps and areas of improvement for compliance to regulatory requirements.

• Conduct sponsor QA oversight audits of Bioanalytical phase for outsourced BA/BE Studies.

• Review study documents (e.g. study protocol, Bioanalytical method validation raw data/ reports and Bioanalytical study raw data/ reports etc.) of BA/BE studies in order to ensure compliance with applicable guidelines, regulations and Good Documentation Practice (GDP).

• Review Bioanalytical study templates, Bioanalytical Method validation templates, SOPs, Annexure, ATP/ Method SOP, instrument qualification (IQ/OQ/PQ/DQ) etc.

• Create (review and/or coordinate) & implement Quality Assurance (QA) Standard Operating Procedures (SOPs) and global documents (GQSs/ GSOPs). Review and support creation of operational level SOPs in collaboration with relevant stakeholders at R&D. Harmonize systems and processes with other GCP / GLP sites wherever feasible.

• Perform other QA audits like System/Facility/Process based audits.

• Conduct Contract Research Organization (CRO) / Contract Service Provider (CSP) / Material supplier Qualification/ Re-qualification audits.

• Review Deviation, Incident, Investigation, CAPA and change control etc.

• Perform trend analysis of deviations, CAPA, change control, incident etc. Support activities of the Quality Review Board (QRB) for continuously improving the quality system.

• Review response to regulatory queries.

• Review and approve documents related to Computer System Validation.

• Prepare audit reports within timely manner; identify any non-compliance/ non-conformance and escalate any critical issue immediately with the senior management (Head, R&D GCP QA/ Head- Site GCP QA and Quality R&D Head), as applicable.

• Support creation of appropriate Corrective Action and Prevention Action (CAPA) plan and its execution to meet necessary compliance standards. Verify adequacy of all created & executed CAPAs.

• Assist Head - R&D GCP QA/ Head - Site GCP QA to coordinate regulatory inspection in collaboration with other R&D stakeholders. Support and implement appropriate CAPA for the identified gaps and resolution of regulatory queries in a time bound manner.

• Responsible for document control and document management.

• Impart training or assist in imparting training on applicable guidelines, regulations, SOPs etc.

• Responsible to ensure GxP Computerized Systems at site are in compliance with the current regulatory standards. (Computerized systems include Firmware based device, embedded systems, Process Control Systems- HMI/IPC, PLC/SCADA, Spreadsheet etc.).

• Perform the GxP computerized systems assessment and support remediation for ensuring 21 CFR part 11, EU Annex 11 readiness, adequate security and controls.

• Execute any other work allotted by the reporting authority.

List of Competencies Required:

Technical Competencies:

• Graduate/ Post graduate degree in basic sciences with at least 06-07 years of experience in GCP/ GLP environment of which at least 05 years of experience must be in Quality Assurance

• Good understanding of international GCP/ GLP regulations and clinical research processes including outsourcing of studies

• Experience of qualification of CRO/CSP/ Material suppliers

• Experience of conducting internal and external audits

• Good auditing skills

• Good knowledge of IT/computer systems

Behavioral Competencies / Soft Skills:

• Good problem solving skills

• Customer centricity

• Teamwork skills

• Good written and verbal communication skills

• Ability to work independently

Sun Pharmaceutical Industries