Role: QA Auditor
Exp: 6+Years
Location: Bangalore
Key Responsibilities:
- Plan, schedule, conduct, and close GLP audit activities across applicable countries.
- Evaluate audit findings and distribute reports to operations, management, and customers.
- Provide regulatory interpretation and compliance guidance to project teams.
- Advise customers on audit observations and corrective action plans.
- Manage quality issues and support RCA, CAPA, EC reviews through closure.
- Deliver educational programs and compliance training to operational staff.
- Support quality events in eQMS and maintain audit lifecycle documentation.
- Host customer audits and support regulatory inspections.
- Lead, collaborate, and participate in quality/process improvement initiatives.
- Assist in onboarding/training new QA staff.
- Provide QA consultancy services to clients within timeline and budget.
- Review organizational policies/procedures for regulatory alignment and recommend improvements.
Qualifications:
- Bachelor's degree required.
- 79 years in pharmaceutical/technical domains, including at least 3 years in Quality Assurance; GxP experience preferred.
- Strong knowledge of pharmaceutical R&D and regulatory environments.
- Excellent communication, problemsolving, risk assessment, negotiation, and training skills.
- Ability to work independently, manage multiple projects, and collaborate effectively with crossfunctional teams.
Notes from Hiring Manager Discussion:
- Looking for GLP auditors experienced in auditing labs for clinical trials.
- Will work primarily with the India team; may have calls with vendors from the EU and Japan.
- No travel needed for contractors.
- Key skills required: GLP, GCP, QMS, regulatory knowledge, communication, negotiation, and crossfunctional collaboration.
- This role is more functional than technical, and the manager places strong emphasis on quality.
