Job Description:
- Schedule, personally conduct and/or manage resources, for Good Clinical Practice (GCP), and CFR/Annex Part 11 audits which will support Clinical Operations activities including but not limited to :
- Develop risk based audit planning focusing on medical care of subjects/patients and adherence to protocols and GCPs for of clinical (BE /BA) operations and clinical site audits.
- Provide oversight for and participate in audits of clinical (BE /BA) operations, clinical sites and review clinical, pharmacokinetic/ statistical data and documents that will be submitted to regulatory authorities.
- Provide oversight of Clinical QA auditors to develop specific audit plans, review and assess internal audit reports to ensure they have met the audit plan and that recommendations and suggested Corrective Action Preventative Action Plans (CAPA) are adequate all to ensure compliance with Standard Operating Procedures (SOPs), Regulations, and Best Practices.
- Collaborate with the appropriate Clinical Operations team in follow-up to clinical audits to ensure resolution of audit findings in accordance with industry best practices.
- Collaborate with Clinical Operations in lessons learned debrief to identify the need for continuous improvement and for potential changes to work practices.
- Consult with Clinical Operations regarding perceived GCP related vendor performance issues and when indicated work with them to develop a corrective action plan.
- When indicated perform remote vendor audits and provide follow-up as indicated.
- Provide follow-up corrective action with proposed and contracted vendor services.
- Lead/assist with investigations of misconduct, serious GCP breach and other noncompliance issues.
- Identify and appropriate escalate critical quality issues to GCP QA HOD.
- Perform / Oversee and root cause analysis (RCA) and corrective action preventative action (CAPA) process.
- Perform /Oversee internal process audits, due diligence, system audits, GCP document audits including trial master file (TMF), and 21CFR part 11 audits.
- Periodically maintain and report GCP QA team activity metrics, study quality metrics and trends for assigned program(s) to GCP QA HOD
- Assist GCP QA HOD/management in the readiness and hosting of regulatory agency inspections
Candidate Profile
• Master Degree in basic medical sciences / pharmacy/pharmacology with at least 12 years related experience in GCP Quality Assurance and Clinical Quality Management Systems.
• Minimum experience required: 10 years in performing and managing Clinical Quality • Assurance audits in GCP environment and with at least 6 years in team managing capacity.
• Through knowledge in regulatory guidelines (ICH, USFDA, EMA, MHRA,) governing clinical development.
• Highly motivated, agile and organized individual who can function in a fast-paced, multi-tasking environment. Able to work independently and as part of a multi-disciplinary team
• Strategic thinking and goal oriented with demonstrated good judgment and decision-making experience in a matrix environment
• Excellent attention to detail, time management and investigative skills, able to manage multiple priorities with urgency and thoughtful planning
• Must have strong written and oral communication skills in English language.
Experience working with MS Office (Excel, Word, PowerPoint)
• Master Degree in basic medical sciences / pharmacy/pharmacology with at least 12 years related experience in GCP Quality Assurance and Clinical Quality Management Systems.
• Minimum experience required: 10 years in performing and managing Clinical Quality • Assurance audits in GCP environment and with at least 6 years in team managing capacity.
• Through knowledge in regulatory guidelines (ICH, USFDA, EMA, MHRA,) governing clinical development.
• Highly motivated, agile and organized individual who can function in a fast-paced, multi-tasking environment. Able to work independently and as part of a multi-disciplinary team
• Strategic thinking and goal oriented with demonstrated good judgment and decision-making experience in a matrix environment
• Excellent attention to detail, time management and investigative skills, able to manage multiple priorities with urgency and thoughtful planning
• Must have strong written and oral communication skills in English language.
Experience working with MS Office (Excel, Word, PowerPoint)
Personal Attributes Needed.
• Ability to work with cross functional groups /teams and handle difficult people/situations under pressure.
• Ability to communicate clear and accurate audit observations based on regulatory requirements and best practice, which gains acceptance from auditees.
• Ability to work with the senior management level in QA and with other partnering departments of business units.
• Ability to deal with competing timelines.
• Ability to work independently and as part of a team.
• Ability to prioritize work and handle multiple assignments.
• Ability to work with cross functional groups /teams and handle difficult people/situations under pressure.
• Ability to communicate clear and accurate audit observations based on regulatory requirements and best practice, which gains acceptance from auditees.
• Ability to work with the senior management level in QA and with other partnering departments of business units.
• Ability to deal with competing timelines.
• Ability to work independently and as part of a team.
• Ability to prioritize work and handle multiple assignments.
Additional Information
Qualification : M.Sc, M.Pharm
Location : India
Industry Type : Pharma
End Date : 10th January, 2019
Qualification : M.Sc, M.Pharm
Location : India
Industry Type : Pharma
End Date : 10th January, 2019
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