EUQA Specialist/ Auditor

We are seeking a highly motivated and experienced Quality Assurance Specialist / Auditor to join our international Quality team. The successful candidate will play a key role in ensuring compliance with EU and international regulatory requirements through the management of Quality Agreements, supplier qualification, and oversight of Contract Manufacturing Organizations (CMOs). This position involves conducting audits, managing QMS processes, and coordinating cross-functional Quality projects to maintain the highest standards of GMP compliance and product quality.

Key Responsibilities

· Quality Agreements:

Draft, negotiate, implement, and maintain Quality Agreements with suppliers, CMOs, and partners in accordance with internal policies and regulatory expectations.

· Supplier and CMO Qualification:

Lead and support supplier qualification activities, including documentation review, risk assessment, and supplier performance monitoring.

Plan, conduct, and follow up on audits of CMOs, suppliers, and service providers to ensure compliance with EU GMP and other relevant international standards.

Review and approve audit reports and ensure timely closure of audit observations.

· Regulatory and Compliance Oversight:

Continuously review EU and international regulatory guidelines (e.g., EMA, EU GMP, ICH) to assess and communicate the impact on existing quality systems and processes.

Support implementation of new or revised requirements within the company’s Quality Management System (QMS).

· Quality System Management:

Coordinate and support Quality Assurance projects aimed at system improvement, harmonization, and compliance enhancement.

Manage and support QMS elements including Change Control, Complaints, Deviations, CAPA, and Document Management.

Contribute to internal and external inspection readiness activities.

· Cross-functional Collaboration:

Work closely with Manufacturing, Regulatory Affairs, Supply Chain, and Aurobindo Affiliates to ensure quality and compliance objectives are met.

Qualifications & Experience:

· Bachelor’s or master’s degree in pharmacy, Chemistry, Biotechnology, Life Sciences, or a related discipline.

· Minimum of 5 years of experience in Quality Assurance or Quality Auditing within the pharmaceutical or biotechnology industry.

· Proven experience in GMP auditing (internal and external) and supplier qualification.

· Strong knowledge of EU GMP, EMA guidelines, and global regulatory expectations.

· Experience in drafting and managing Quality Agreements.

· Excellent understanding of QMS processes (Change Control, CAPA, Deviations, Documentation).

· Qualified Person (QP) status according to EU Directive 2001/83/EC is considered a strong advantage, but not mandatory.

· Fluent in English (both written and spoken); additional languages are an asset.

· Strong communication, negotiation, and project management skills.