BA/BE: Section
- Quality Control Plan Execution: Develop and oversee the implementation of the Quality Control Review Plan (QC) for each study, ensuring meticulous execution and adherence to standards.
- Monitoring and Oversight: Monitor protocol compliance and documentation, conduct clinical study conduct reviews, and ensure the integrity of study processes through a robust quality control plan execution.
- Quality Control Processes Definition: Establish Quality Control Review processes to:
- Manage the review and approval of draft source documents, ensuring alignment with the protocol, HPU SOPs, ICH GCP (E6), and other relevant regulatory guidelines.
- Verify screening charts for accuracy of Inclusion/Exclusion criteria, informed consent form (ICF) documentation processes, and Investigator/Sub-investigator review activities.
- Ensure comprehensive review of all source documents against quality control standards as outlined in the QC Plan.
- Conduct reviews of study day records to confirm data completeness, consistency with protocol requirements, and adherence to good documentation practices and ALCOA+ principles.
- Documentation and Compliance: Ensure that the Quality Control Review process is thoroughly documented, with all QC observations and protocol deviations addressed and resolved in a timely manner before data entry.
- Verification and Reporting: Lead the Quality Control Review team in verifying source data against electronic Case Report Forms as stipulated in the QC Plan. Communicate any issues or deviations in protocol to clients, the Principal Investigator (PI), and the VP & OU Head of Clinical Development.
- Client and Team Interaction: Meet regularly with clients to discuss protocol adherence, address any deviations, and report on consistent QC observations.
- Resolution Deadlines: Establish and enforce deadlines for resolving queries, ensuring prompt compliance.
- Regulatory Documentation Review: Oversee the QC review of the Regulatory/TMF Binder at the conclusion of the study, ensuring readiness for archiving.
- Error Analysis and Liaison Duties: Analyze the nature and cause of errors to identify areas for improvement within departmental processes and systems. Serve as a liaison between staff and management to discuss error trends and areas of concern.
Bioanalytical Laboratory operations Section activities
- Data Integrity and Review: Conduct comprehensive checks on method development, validation, sample analysis, concentration data, and database locks to ensure data integrity across all studies.
- Document Review for Compliance: Scrutinize all study documents to confirm readiness for Quality Assurance Unit (QAU) review, adhering to planned timelines for each review process.
- Collaborative Problem Solving: Engage directly with the study director to discuss observations, propose solutions, and reach consensus on Corrective and Preventive Actions (CAPA).
- Audit Support: Provide robust support during all QAU, sponsor, and regulatory audits, ensuring all practices meet required standards.
- Facility Oversight: Perform routine facility inspections to maintain the facility’s condition and ensure that all related documentation is up to date.
- Quality Control of Laboratory Practices: Regularly review laboratory logbooks and check the calibration and validation status of equipment to maintain operational standards.
- Data Trend Analysis: Analyze Quality Control observations monthly to support the Head of Department (HoD) in driving quality transformation initiatives.
- Drive sustainable quality improvement in lab operations: Spearhead the Quality Circle initiative, providing weekly updates to the HoD on progress and outcomes. Work closely with technical teams to drive sustainable quality improvement in all lab operation.
- Resource Allocation: Efficiently allocate staff for study reviews to ensure optimal team performance and study coverage.
- Standard Operating Procedures Support: Assist in the development and revision of Standard Operating Procedures (SOPs), participating actively in their preparation.
- Efficient Data Review: Manage the simultaneous review of multiple studies’ data, ensuring an efficient and effective process
Central laboratory section activities
- Comprehensive Quality Checks: Oversee Pre-Analytical, Analytical, and Post-Analytical activities, ensuring all procedures adhere to the established Quality Control Standard Operating Procedures (QC SOP).
- Data Entry Verification: Ensure that all manually transcribed data is accurately captured and corresponds with the respective worksheets, guaranteeing data integrity.
- Logbook Management: Maintain strict control over logbook entries to ensure all records are legible and properly managed within the Clinical Laboratory (CLAB). Ensure that logbooks are maintained and controlled according to laboratory standards.
- Quality Control Data Review: Conduct daily reviews of Quality Control data across multiple disciplines, including Clinical Biochemistry, Hematology, Serology, Coagulation, and Clinical Pathology, to ensure consistency and accuracy.
- Non-Conformance (NC) Logbook Implementation: Manage the Non-Conformance logbook, identifying areas for improvement and implementing necessary changes to enhance laboratory processes.
- Instrument Maintenance and Calibration: Maintain rigorous follow-up of instrument preventive maintenance schedules and calibration records, ensuring all equipment operates according to industry standards and regulatory requirements.
Clinical trials, data management, statistics, and pharmacy section activities
- Internal System Reviews: Conduct internal reviews of the Clinical Trial Management department and Syngene Clinical Supply Unit (SCSU) to ensure compliance with Standard Operating Procedures, Good Clinical Practice, and regulatory requirements in line with the Quality Management Plan.
- SOP and Training Review Coordination: Oversee the review of Standard Operating Procedures (SOPs) and assess the need for updates in training binders, ensuring all documentation supports current practices and regulatory standards.
- Quality Issue Reporting: Promptly inform the Department Head or designated representative about significant quality issues. Ensure reporting aligns with established operating procedures or work instructions, with a focus on patient safety, regulatory compliance, and data integrity.
- Syngene Clinical Supply Unit Quality Checks: Perform comprehensive quality checks within the Syngene Clinical Supply Unit as part of the Clinical Trial Management oversight to uphold system integrity.
- Database and Code Quality Control: Execute quality control checks on databases and associated programs or codes as specified in the Quality Control plan to maintain accuracy and functionality.
As a Syngene leader:
- Champion effective Environment, Occupational Health, Safety, and Sustainability (EHSS) practices for the company, and oversee compliance with those practices within the IDD team. Play an active leadership role in monitoring and verifying safety performance through GEMBA walks and other safety-led activities.
- Foster a corporate culture that promotes an environment, occupational health, safety and sustainability (EHSS) mindset as well as the highest standards of quality, integrity and compliance.
- Put people at the heart of Syngene’s success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning, and talent retention as a priority.
Education and Experience
Education
M. Pharm, MSc – Post graduate degree in life sciences, Minimum required. PhD will be added advantage.
Industry Experience
At least 15 years’ experience in working in GxP and compliance environment. Deep understanding of process and compliance in GxP environment. Experience and exposure to GCP and GLP areas is critical experience criteria.
People leadership experience
At least 7 years’ experience in leading teams directly and working with cross functional teams in a metrics organization.
International exposure and experience
Not required, but desirable if any.
Other competencies required for the role
- Excellent people skills with extensive experience in leading change, and a proven ability to instill a culture of collaboration.
- Keen interest in scientific innovation in a commercial setting.
- Strong customer and service delivery mindset with a proven track record in delivering business growth.
- High degree of results orientation with a track record of growth and delivering against targets.
- Well networked and strong industry knowledge.
- Confident and well-practiced language and interpersonal skills
- Impeccable ethics and integrity along with an exposure to a multi-cultural work environment.