Senior GCP Advisor
Bengaluru, India
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Other
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Full-time
Job Reference: 6403 - Posted 31-Jan-2024
Job Title: Senior GCP Advisor
Location: Bangalore
Experience: 10 to 15 Years
Qualification: Degree in medical/biological/pharmaceutical science or similar
Skillsets: GPC , GCP regulations , Clinical trials
Job Purpose:
As a Senior GCP Advisor, your primary responsibility is to manage Content Control/Process Management processes for Clinical trials and ensure compliance to GCP regulations on behalf of the Process Quality Assurance (PQA). You will be serving as a GCP Advisor and be a member of the Clinical Trial (CT) SOP Council where you advice line of business regarding quality concerns, ensuring quality mind-set. Your role also involves in providing support during GCP inspections.
Roles and Responsibilities:
- Verify and approve Standard Operating procedures (SOPs) and right interpretation of GCP regulations as quality advisor.
- Collaborate with Process Manager in a process group, following Process Management guidelines. Regularly communicate with Process Quality Assurance Delegate (PQAD) to share insights.
- Ensure maintenance of global CT SOPs and ensure compliance with internal & external requirements. Attend CT SOP council meetings and raise/present/discuss relevant quality concerns.
- Capability to completely work independently leveraging robust GCP knowledge and being relevant with changing regulations and QMS needs.
- Provide support to stakeholders in and outside R&D Quality during GCP inspections as applicable.
- Ensure global consistency and compliance in clinical development process through process documentation, information sharing, and guidance. Be quality anchor for worldwide clinical development process.
Job Description:
- Pharmaceutical business and knowledge of GCP regulations and guidelines within drug development.
- Extensive experience in conducting clinical trials.
- Experience of overall QMS and quality processes.
- Experience with audits and inspection support.
- Thorough knowledge and understanding of the drug development and life cycle management processes, preferably from participation in project teams.
- Global cross functional experience.
- Team player prepared to work in a dynamic international environment with tight deadlines.
- Ability to influence and set directions.
- Strong personal leadership skills and quality mindset.
- Display strategic -set – with focus on optimising the way processes are handled in NN.
- Project management skills and ability to co-ordinate and facilitate globalised processes.
- Flexibility and team-oriented ready to re-prioritize and adapt to changes in continuously evolving environment.
- Ability to present complex quality issues in a global environment effectively.
- Work independently and lead with clear and confident decision making.
- Sound IT skills and demonstrate excellent presentation and communication skills.