Qualified Person

SUN PHARMA; Hoofddorp; On-site; EUR 70,000 - 110,000; Full time

Benefits offered by this job

25 holidays + 1 extra day off on your

International environment

Job summary

SUN Pharma in the Netherlands seeks a Qualified Person to lead batch release and IMP certification for European and non‑European trials, ensuring compliance with Annex 13/16 and regulatory standards.

The role oversees QMS alignment, deviation/change control reviews, and supports inspections readiness while coordinating with global QA teams to uphold high pharmaceutical quality across commercial and clinical programs.

Qualifications

• Master’s Degree or equivalent in Chemistry, Pharmacy or relevant scientific field.
• Qualified Person certification or credential.

Responsibilities

• 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.
• Review and prepare batch documents for QP Batch certification of clinical trial batches, and ensure proper maintenance of product specification files.
• Maintain compliance to European and local regulatory procedures for the management of clinical trials as per Good Clinical Practices (GCP).
• Support QMS: assist in implementing global standards and procedures, GAP assessments, and inspection readiness for external audits.
• Involvement in new projects and knowledge sharing of GxP requirements.

Skills

GxP Knowledge

EU GMP Knowledge

EU GDP Knowledge

Project Management

Communication Skills

Education

Master’s Degree in Chemistry, Pharmacy or relevant scientific field

Qualified Person

Job description

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

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

What we offer

25 holidays + 1 extra day off on your birthday

International environment