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:

Bachelors 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.

QA Auditor with GLP