Job Description

OBJECTIVES

Clinical QA will be responsible for managing clinical quality function at LOC-India, reporting to Quality Head. Develop, control and continuously improve existing clinical quality systems and processes. Work in close collaboration with the clinical operation team ensuring adherence to Good Clinical Practice guidance’s, local clinical trial regulations and internal procedures.

Key Responsibilities

• Contribute to the development of local QMS (including GCP compliant process development) for managing local Clinical trial quality assurance in accordance with internal procedures.
• Creation and implementation of Clinical Quality Assurance procedures and act as cross functional reviewer (where applicable) and quality authorizer as per internal procedures.
• Coordinate and contribute to the development of risk based GCP supplier audit and compliance strategy
• Develop, maintain and lead the supplier audit management plan in accordance with internal procedures.
• Lead supplier and individual clinical study audit(s) (internal and external including clinical site(s)) in accordance with internal procedures
• Provide independent quality and compliance oversight for GCP suppliers, including but not limited to coordinating the development and execution of Quality Agreements, attending Governance meetings etc.
• Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks such as any Critical findings noted during supplier audit to be notified to Local Management on an immediate basis (as required by Takeda Audit procedure)
• Performing and reviewing GAP assessments in collaboration with Functional Team and LOC QA (where required, for QA procedure GAP assessments)
• Ensure audit reports (both external and internal process audits) and CAPA actions are developed, reviewed by Local Management (where required) and completed, escalated when required, within timelines mandated in internal procedures.
• Support core governance for deviation/incident management for critical or major deviations pertinent to the clinical trials being assigned. Review and approve them as deemed necessary.
• Guiding Clinical Operations for adequate root cause identification, conducting gap analysis and implementation of corrective action plan (CAPA).
• Generate metrics and develop reports on GCP supplier quality performance
• Collaborate with cross functional team and Quality Compliance and Systems team to identify and mitigate supplier related quality and compliance issues
• Escalate critical problems and recommend appropriate solutions to Local management for immediate and long-term resolution
• Provide GCP guidance to day to day questions arising from Clinical trials deliverables, as well as participate in review and approval of critical Clinical Study documents (e.g., Protocols), as appropriate
• Provide guidance to internal Takeda stakeholders such as clinical operations team, Clinical supply, regulatory affairs and external supplier or Business Partner (as applicable) for day to day questions arising from Clinical trials deliverables pertaining to GCP compliance requirements, supplier governance and supplier quality oversight procedure & initiatives. as well as participate in review and approval of critical Clinical Study documents (e.g., Protocols), as appropriate
• Ensure adequate (follow ALCOA principle) management and maintenance of Local Quality Assurance records
• Ensure compliance to internal training and documentation procedures
• Participate in GCP health authority inspections as required
• QA support in PV & RA gap assessment quality review
• Providing inputs as local QA personnel on PV deviations
• Performing risk assessment of local GPvP vendors and schedule the audit accordingly.
• Execution of Local GPvP vendor audit plan. Maintaining oversight if audit conduct shall be outsourced to consultant auditor.

Education

• Life Sciences Graduate/Postgraduate with 7-10 years of years’ experience in clinical trial industry as Clinical Quality Auditor
• Strong Analytical skills
• Excellent knowledge of cGxPs, quality standards and industry best practices
• Analytical skills, Attention to detail, Good communication skills, solution oriented, ability to work on multiple projects, plan, organize and prioritize activities
• Proven/stable performance records over the past 2 – 3 years
• Good knowledge and understanding of the pharmaceutical industry, local clinical trial regulations and understanding of ICH E6, ICH E3, ICH E8, ICH E9

Locations

IND – Gurgaon

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time

Apply through below link

Clinical Quality Manager | Takeda | LinkedIn