QP

pThe Senior Qualified Person (QP) will be responsible for certifying the release of IMPs for clinical trials in compliance with European and international GMP (Good Manufacturing Practice) standards. This role is critical to ensuring that Sun Pharma’s investigational products meet stringent quality and safety standards, enabling them to be used confidently in clinical studies. The QP will collaborate closely with cross-functional teams including Regulatory Affairs, Clinical, and Quality Control. Supports the QMS that consolidates Health Authority Regulations into Sun Quality requirements. /pbrLees verder om te ontdekken wat u nodig heeft om te slagen in deze functie, inclusief vaardigheden, kwalificaties en ervaring.brMajor Responsibilitiesbr1. IMP Release and Certificationbrullibr/liliCertify the release of Investigational Medicinal Products (IMPs) for clinical trials in accordance with EU GMP Annex 13 requirements and IMP Product Specification File.br/liliEnsure compliance with regulatory requirements and quality standards, confirming that all IMPs are manufactured, tested, and documented in accordance with applicable guidelines.br/li /ulbr2. Quality Oversight and Compliancebrullibr/liliProvide quality oversight of manufacturing, testing, and distribution activities to ensure compliance with GMP and Good Clinical Practice (GCP).br/liliLead investigations related to deviations, CAPAs (Corrective and Preventive Actions), and change controls impacting IMPs, ensuring timely resolution and adherence to quality standards.br/liliSupport audits and regulatory inspections as a primary point of contact for IMP quality matters, including responding to findings and implementing improvements.br/liliSupport the maintenance and update of Quality Management System.br/liliSupport planning and inspection readiness for external audits (from partners, Corporate Quality Systems and regulatory authoritiesbr/li /ulbr3. Documentation and Batch Record Reviewbrullibr/liliReview and approve batch manufacturing records, validation protocols, analytical data, and product specifications to verify adherence to GMP requirements.br/liliMaintain accurate and complete documentation of all release activities, ensuring compliance with applicable regulatory and company standards.br/li /ulbr4. Regulatory Compliance and GMP Guidancebrullibr/liliStay updated on evolving EU and international GMP regulations, sharing relevant changes and insights with internal stakeholders.br/liliProvide guidance and support on GMP requirements for IMPs, working closely with project teams to ensure seamless adherence to regulatory requirements.br/li /ulbr5. Training and Developmentbrullibr/liliProvide training and mentorship to Quality Assurance staff and cross-functional team members on GMP and quality requirements for IMPs.br/liliAct as a subject matter expert on IMP quality issues, supporting training initiatives and fostering a culture of compliance and continuous improvement.br/li /ulbrQualifications, Knowledge, Experience SkillsbrEducation Qualifications (Graduate- Post Graduate)brMandatorybrullibr/liliBachelor’s or Master’s degree in Pharmacy, Biotechnology, Chemistry, or related field.br/liliQP Certification: Must be a certified Qualified Person (QP) recognized under EU Directive 2001/20/EC with IMP certification experience.br/li /ulbrMandatorybrullibr/liliMinimum of 5 years of experience in Quality Assurance or a similar role within the pharmaceutical industry, with a strong focus on IMPs.br/liliIn-depth knowledge of EU GMP, GCP, and applicable regulatory requirements for clinical trials.br/liliStrong problem-solving and analytical skills with a meticulous attention to detail.br/liliExcellent written and verbal communication skills in English.br/liliAbility to work effectively in cross-functional teams and manage multiple priorities in a fast-paced environment.br/li /ulbrPreferred Skillsbrullibr/liliExperience in regulatory inspections (e.g., EMA, MHRA).br/liliFamiliarity with quality management systems (QMS) and electronic documentation systems.br/li /ulbrBehavioral Skills/Competencies (e.g. excellent communication skills, strong collaborator, Problem solving etc.)brullibr/liliStrong interpersonal skills, excellent communication skills, good presentation, negotiations and influencing skillsbr/liliAbility to effectively manage multiple, complex priorities and quick shifting of those.br/liliTeam player, task oriented and keen on working in a cross-cultural working environment. xgiwjmb br/liliPeople oriented with tendency to help others and go beyond her/his area of responsibility.br/li /ulbr