Senior GCP Advisor

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.