Key Skills

Job Description

Overall Job Purpose SUN Pharma is seeking a dynamic Qualified Person who will play a pivotal role in ensuring the batch release and certification of our products for commercial use in Europe. Taking the helm of the Pharma Branded team, he/she will foster a culture of excellence in quality management. Serving as the Qualified Person for IMPs certification, the selected candidate will provide invaluable advice and support for quality aspects in both European and non-European clinical trials. Join us in upholding the highest standards in pharmaceuticals on a global scale! Major tasks & responsibilities 1) Be responsible for batch release and certification of IMPs and Pharma Branded products as primary Qualified Person; as stipulated in Annex 13 and 16 of Eudralex Vol 4: Ensures timely release and certification, to meet commercial planning or clinical trial timelines Ensures maintenance of product specifications in accordance with current Marketing Authorization or Investigational Medicinal Product Dossier Review of quality control aspects of API and finished clinical or commercial product Review and assessment of associated deviation reports and change control reports Review and assessment of corrective and preventive actions. Review and assessment of transport conditions associated to commercial or clinical batch importation 2) Review and prepare batch documents for QP Batch certification of clinical trial batches, and ensure proper maintenance of product specification files to ensure compliance with IMPDs where applicable. 3) Integrate procedures from various systems & processes for clinical trials: Maintain compliance to European and local regulatory procedures for the management of clinical trials as per Good Clinical Practices (GCP) Support in establishment of local procedures and Company Global Quality Standards (if necessary) for management of clinical trials within Europe Management of Quality related deviations (initiation, investigation, closure) related to clinical trials 4) Support QMS: Work closely together with the Quality Management System team to support the timely implementation of global standards and procedures by execution of associated GAP assessments against local procedures. Support the maintenance and update of Quality Management System. Support planning and inspection readiness for external audits (from partners, Corporate Quality Systems and regulatory authorities 5) Support business as required: Involvement in new projects Knowledge and experience sharing of GxP requirements Reviewing the proposal for optimization and process improvements from CMOs for Branded and IMPs All above as part of the requirements of Regulation No.1252/2014 and Directive2003/94/EC Key Performance Indicators/result areas: Timely batch release of IMPs and Branded products. All areas linking to Batch Certification. Smooth co-operation with cross-functional teams to ensure regulatory and corporate compliance. Continuous Improvement project involvement. Successful inspection readiness. Quality Management Support. Qualifications, Knowledge, Experience & Skills Education Qualifications (Graduate- Post Graduate) Mandatory Master’s Degree or equivalent in Chemistry, Pharmacy or relevant scientific field. Qualified Person Work experience Mandatory Minimum three (3) years’ experience in pharmaceutical industry in job related to Quality aspects (manufacturing QA, packaging QA, Quality Control, batch review, batch release) Minimum two (2) years’ experience in pharmaceutical industry with clinical operations and quality assurance tasks in management of clinical trials in Europe Preferred Experience in the batch certification process Technical skills/job specific competencies Technical understanding of EU GCP Guidelines. Technical understanding of manufacturing processes and EU GMP Guidelines. Technical understanding of manufacturing processes and EU GDP Guidelines. Management of priority concurrent projects Skills/Competencies (e.g. excellent communication skills, strong collaborator, Problem solving etc.) Ability to give and take direction Ability to self-motivate Team-member attributes What we offer 💼 Flexible working scheme 🏝️ 25 holidays + 1 extra day off on your birthday 🏥 Health insurance 🌟 Growth Opportunities 🌐 International environment If this sounds like you, Apply via the “Apply Now” button Note: NO RECRUITMENT AGENCIES TO CONTACT SUN PHARMA ABOUT THIS ROLE. Applicants must apply themselves and any unsolicited agency referrals will be deleted

Core Responsibilities

Responsible for the batch release and certification of Investigational Medicinal Products (IMPs) and Pharma Branded products for the European market. The role involves managing quality aspects of clinical trials, maintaining QMS compliance, and ensuring inspection readiness for regulatory audits.

Requirements

Requires a Master's degree in Chemistry, Pharmacy, or a relevant scientific field. Candidates must have at least three years of pharmaceutical quality experience and two years specifically in European clinical operations and quality assurance.

Benefits

• Flexible working scheme
• 25 holidays
• Extra day off on birthday
• Health insurance
• Growth opportunities
• International environment