Senior GCP Advisor

Bengaluru, India    |     Other   |   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.