Quality Assurance – Pharma Services
Bachelor’s degree in a scientific discipline
Minimum 3 years of relevant experience in a Quality Assurance or Compliance-related role in a pharmaceutical, biotechnology or related environment preferably for pharmacovigilance or clinical research activities
Skills and competency requirements:
· Able to work as a team player: listen, promote exchanges, communicate, adapt and advise.
· Demonstrated knowledge and understanding of GCP and GVP regulations.
· Experience conducting audits.
· Excellent verbal and written communication skills.
· Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
· Analytical thinker with problem solving skills and the ability to adapt to changing priorities and deadlines.
· Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
· Responsible for executing GxP Quality Assurance (QA) with an emphasis on the Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) auditing and compliance by drafting and reviewing standard procedures for operations
· Performs internal and external audits as assigned to assure compliance with GCP and GVP regulations and guidelines
· Supports Quality Management System (QMS) including, but not be limited to, the following activities:
Contributes to QA review of Pharmacovigilance documentation such as PSMF, process documents and regulatory submissions.
Prepare and reviews GCP and GVP compliance related SOPs.
Assists in identifying and communicating process-related risks and opportunities for process improvement.
Tracks CAPA implementations.
· Contributes to organizations’ understanding of worldwide pharmacovigilance regulations, guidelines and GxP practices and assists in helping to meet regulatory compliance and corporate business requirements.
· Assists with GXP inspection readiness activities for regulatory authority inspections and coordinates tracking of document requests, responses and supporting documentation during inspections.
Contract length: 12 months
To apply, Contact HR: +91 9087594555 to schedule an Interview