Requirements: English
Company: SUN PHARMA
Region: Hoofddorp , North Holland
QP for Investigational Medicinal Products (IMPs)
Overall Job Purpose:
The Qualified Person (QP) for Investigational Medicinal Products (IMP) 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 Pharmas 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.
Major Responsibilities:
1. IMP Release and Certification
- Certify the release of Investigational Medicinal Products (IMPs) for clinical trials in accordance with EU GMP Annex 13 requirements and IMP Product Specification File.
- Ensure compliance with regulatory requirements and quality standards, confirming that all IMPs are manufactured, tested, and documented in accordance with applicable guidelines.
2. Quality Oversight and Compliance
- Provide quality oversight of manufacturing, testing, and distribution activities to ensure compliance with GMP and Good Clinical Practice (GCP).
- Lead investigations related to deviations, CAPAs (Corrective and Preventive Actions), and change controls impacting IMPs, ensuring timely resolution and adherence to quality standards.
- Support audits and regulatory inspections as a primary point of contact for IMP quality matters, including responding to findings and implementing improvements.
- 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
3. Documentation and Batch Record Review
- Review and approve batch manufacturing records, validation protocols, analytical data, and product specifications to verify adherence to GMP requirements.
- Maintain accurate and complete documentation of all release activities, ensuring compliance with applicable regulatory and company standards.
4. Regulatory Compliance and GMP Guidance
- Stay updated on evolving EU and international GMP regulations, sharing relevant changes and insights with internal stakeholders.
- Provide guidance and support on GMP requirements for IMPs, working closely with project teams to ensure seamless adherence to regulatory requirements.
5. Training and Development
- Provide training and mentorship to Quality Assurance staff and cross-functional team members on GMP and quality requirements for IMPs.
- Act as a subject matter expert on IMP quality issues, supporting training initiatives and fostering a culture of compliance and continuous improvement.
Qualifications, Knowledge, Experience & Skills
Education Qualifications (Graduate- Post Graduate)
Mandatory
- Bachelors or Masters degree in Pharmacy, Biotechnology, Chemistry, or related field.
- QP Certification: Must be a certified Qualified Person (QP) recognized under EU Directive 2001/20/EC with IMP certification experience.
Work experience
Mandatory
- Minimum of 5 years of experience in Quality Assurance or a similar role within the pharmaceutical industry, with a strong focus on IMPs.
- In-depth knowledge of EU GMP, GCP, and applicable regulatory requirements for clinical trials.
Technical Competencies
- Strong problem-solving and analytical skills with a meticulous attention to detail.
- Excellent written and verbal communication skills in English.
- Ability to work effectively in cross-functional teams and manage multiple priorities in a fast-paced environment. Preferred Skills
- Experience in regulatory inspections (e.g., EMA, MHRA).
- Familiarity with quality management systems (QMS) and electronic documentation systems.
Behavioral Skills/Competencies (e.g. excellent communication skills, strong collaborator, Problem solving etc.)
- Strong interpersonal skills, excellent communication skills, good presentation, negotiations and influencing skills
- Ability to effectively manage multiple, complex priorities and quick shifting of those.
- Team player, task oriented and keen on working in a cross-cultural working environment.
- People oriented with tendency to help others and go beyond her/his area of responsibility.