Executive – GDP Compliance | Advanz Pharma
Location: Andheri (East), Mumbai, India (Hybrid Working)
Company: Advanz Pharma
About Advanz Pharma
Advanz Pharma is a global pharmaceutical company committed to improving patients’ lives by providing and enhancing specialty, hospital, and rare disease medicines. With operations across Europe, Canada, Australia, and India, Advanz Pharma partners with innovative biopharma and pharmaceutical development companies to bring essential medicines to patients worldwide.
Headquartered in London, UK, Advanz Pharma employs approximately 700 professionals across 20+ countries. Its Centre of Excellence in Mumbai supports global distribution, commercialization, and medical operations. The company’s portfolio and pipeline cover therapeutic areas including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and rare diseases.
Advanz Pharma fosters a culture of entrepreneurship, speed, and integrity, empowering employees to drive results while ensuring patient safety and regulatory compliance.
Role Overview
The Executive – GDP Compliance is responsible for ensuring that Advanz Pharma operations comply with Good Distribution Practice (GDP) guidelines, local regulations, and the company’s Quality Management System (QMS). This includes monitoring global transportation routes, maintaining compliance documentation, coordinating recalls, and supporting inspections.
This role is key to maintaining product integrity, regulatory compliance, and supply chain excellence, safeguarding the safety and efficacy of pharmaceutical products.
Key Responsibilities
GDP Compliance and Supply Chain Oversight:
Document, verify, and periodically review global transportation routes for all Advanz Pharma products in collaboration with the Supply Chain department and external vendors.
Assess temperature monitoring and control requirements for transportation routes.
Ensure compliance with validated transport routes and regulatory guidelines.
Maintain contracts with third-party distributors and contract acceptors.
Regulatory and Quality Management:
Support implementation and maintenance of an effective Quality Management System (QMS).
Assist in maintaining Wholesaler/Dealer Authorizations and Controlled Drugs licenses.
Coordinate the supply of controlled drugs inventory information to relevant authorities.
Facilitate product recall operations as per company procedures.
Ensure GDP-related customer complaints are addressed and documented effectively.
Maintain complete records related to GDP compliance and report suspicious activities to senior management and relevant authorities.
Inspection and Continuous Improvement:
Support inspections by regulatory authorities.
Keep updated with current regulations and industry best practices through continuous professional development.
Participate in continuous improvement projects within the GDP compliance framework.
Collaborate cross-functionally to drive the “One Team” ethos and ensure compliance with company values.
Candidate Profile
Education and Qualifications:
Science Graduate (Chemistry, Biology, Pharmacy, or equivalent) or
Postgraduate degree in a related field
Experience Required:
Hands-on experience in European GDP compliance and direct handling of bona fide checks for customers and suppliers.
Strong understanding of QMS, change control, deviation processes, and regulatory compliance.
Experience with SAP Quality modules or VIVA is preferred.
Skills and Competencies:
Ability to work collaboratively with international supply chain partners and internal stakeholders.
Strong organizational skills with the ability to perform under pressure in a fast-paced, regulated environment.
Excellent written and verbal communication skills for reporting, documentation, and cross-functional coordination.
Proactive, self-driven, results-oriented, and adaptable to change.
Competence in Microsoft Excel and PowerPoint.
Commitment to continuous learning, professional growth, and fostering a compliant, ethical culture.
Why Join Advanz Pharma?
Work in an entrepreneurial, inclusive, and fast-paced environment where employees are empowered to make an impact.
Access to flexible working options, competitive salary, and benefits package.
Opportunities for professional growth, promotions, and recognition through annual awards.
Join a global team committed to improving patient outcomes and enhancing the commercialization of specialty and hospital medicines.
Be part of a company promoting gender equality, diversity, and collaboration across international teams.
Application:
Interested candidates should submit a CV and Cover Letter.
Advanz Pharma is an equal opportunity employer, committed to fostering diversity and inclusion. All applications are considered without regard to race, gender, age, disability, sexual orientation, or other protected characteristics.
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