Key Skills

Job Description

About Sun Pharma Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world, with global revenues exceeding US$6 billion. Supported by more than 40 manufacturing facilities and over 40,000 employees worldwide, we provide high-quality, affordable medicines trusted by healthcare professionals and patients in more than 100 countries. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market and continues to strengthen its presence in the specialty pharmaceutical sector, with a focus on dermatology, ophthalmology, and onco-dermatology. Our Values At Sun Pharma, our core values of Humility, Integrity, Passion, and Innovation form the foundation of our culture, known as Sunology. We empower our employees to create their own sunshine by being Better Every Day, Taking Charge, and Thriving Together. We foster an inclusive environment where collaboration, continuous development, and diverse perspectives are valued and encouraged. About the Role We are seeking an experienced and highly motivated Senior Qualified Person (QP) to join our European Quality organization. In this role, you will act as a key Quality leader responsible for the certification and release of medicinal products manufactured at both internal and external manufacturing sites. You will provide strategic quality oversight across commercial and development products, ensuring full compliance with EU GMP, regulatory requirements, Marketing Authorizations, and Sun Pharma Quality Standards. The Senior QP will serve as a subject matter expert and trusted partner to internal stakeholders, Contract Manufacturing Organizations (CMOs), and regulatory authorities. Additionally, the role will support quality strategy development, mentor junior Quality professionals and QPs, and play a critical role in inspection readiness and continuous quality improvement initiatives. Key Responsibilities QP Certification & Product Release Perform batch certification and release of medicinal products in accordance with Article 51 of Directive 2001/83/EC. Ensure all batches are manufactured, tested, and released in compliance with EU GMP requirements and applicable Marketing Authorizations. Review and approve batch documentation, Certificates of Analysis, Certificates of Compliance, deviations, investigations, and all supporting release documentation. Act as Primary or Deputy QP for designated products and manufacturing sites. Quality Oversight & Compliance Provide strategic quality oversight for commercial and development products manufactured at Contract Manufacturing Organizations (CMOs). Ensure quality systems and operations comply with regulatory requirements, company procedures, and Quality Agreements. Lead and support complex deviation investigations, CAPAs, change controls, complaints, and quality risk assessments. Evaluate the impact of quality events on product quality, patient safety, compliance status, and regulatory commitments. Leadership & Stakeholder Management Act as senior quality representative for assigned products and manufacturing sites. Provide guidance and mentoring to junior QPs, QA professionals, and cross-functional teams. Collaborate closely with Regulatory Affairs, Supply Chain, Manufacturing, Technical Operations, Pharmacovigilance, and Quality Control teams. Build strong relationships with CMOs and external partners to ensure effective quality governance and performance management. Regulatory & Inspection Readiness Support regulatory inspections and customer audits as a senior quality representative. Lead inspection preparation activities and oversee implementation of corrective and preventive actions resulting from audits. Ensure ongoing compliance with EU GMP requirements and emerging regulatory expectations. Support regulatory submissions and variations by assessing the quality and compliance impact of proposed changes. Operational Excellence Lead periodic quality reviews and governance meetings with CMOs and internal stakeholders. Support technology transfers, process validation, cleaning validation, and analytical method validation activities from a Quality perspective. Review and approve Annual Product Reviews (APR/PQRs) and product quality metrics. Drive continuous improvement initiatives to strengthen quality systems and operational efficiency. Support implementation of global Quality standards and harmonization initiatives across the organization. Qualifications Education Mandatory Degree (Bachelor's or Master's) in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline. Registered Qualified Person (QP) in accordance with EU legislation. Eligibility to act as a Qualified Person within the Netherlands. Experience Mandatory Minimum 10 years of pharmaceutical industry experience. Minimum 5 years of experience operating as a Qualified Person. Extensive experience within GMP-regulated pharmaceutical manufacturing environments. Proven experience certifying commercial medicinal products. Experience with outsourced manufacturing and Contract Manufacturing Organizations (CMOs). Experience supporting regulatory inspections and external audits. Strong knowledge of sterile and/or non-sterile manufacturing operations. Preferred Experience with biologics, specialty pharmaceuticals, and international supply chains. Previous experience mentoring or leading quality professionals. Experience with clinical trial product certification. Technical Competencies Expert knowledge of EU GMP, GDP, ICH Guidelines, and pharmaceutical regulations. Strong understanding of pharmaceutical manufacturing processes including API, Drug Product, packaging, and distribution. Extensive experience with batch certification and release processes. Strong expertise in quality systems including: Deviations CAPAs Change Controls Complaints Quality Risk Management Supplier Quality Management Experience with TrackWise, eQMS platforms, and electronic document management systems. Ability to assess manufacturing, analytical, validation, and regulatory documentation. Excellent risk assessment and decision-making capabilities. Strong understanding of product lifecycle management and regulatory submissions. Skills & Competencies Exceptional communication and stakeholder management skills. Strong leadership and influencing capabilities. Strategic thinker with a pragmatic, risk-based approach. Excellent problem-solving and decision-making skills. Ability to operate effectively in a fast-paced and complex international environment. Strong organizational and prioritization abilities. Collaborative mindset with a commitment to coaching and mentoring others. High level of integrity, accountability, and professional judgement. Passion for quality, patient safety, and continuous improvement. Why Join Sun Pharma? As a Senior QP at Sun Pharma, you will have the opportunity to play a critical role in ensuring the quality and compliance of medicines supplied to patients worldwide while contributing to the growth of one of the world's leading pharmaceutical companies. You will work alongside experienced professionals in a collaborative, international environment where your expertise will have a direct impact on patient safety and business success.

Core Responsibilities

Certify and release medicinal product batches while ensuring compliance with EU GMP, Marketing Authorizations, and company quality standards. Provide strategic quality oversight for internal and external manufacturing, lead quality investigations and inspection readiness, and mentor colleagues while driving quality improvements.

Requirements

Requires a scientific bachelor's or master's degree, registration as an EU Qualified Person, and eligibility to act as a QP in the Netherlands. Candidates must have at least 10 years of pharmaceutical industry experience, including at least 5 years as a QP, with substantial GMP manufacturing, commercial batch certification, CMO, and audit experience.