Quality Assurance Officer (maternity cover)

SUN PHARMA; Hoofddorp; On-site; EUR 45,000 - 60,000; Full time

Job summary

Sun Pharma is seeking a QA Officer to monitor and maintain product quality and compliance with EU GMP, national legislation, and client guidelines. The role involves reviewing batch documentation, ensuring MA alignment, and coordinating with the Qualified Person.

Responsibilities include batch release documentation, trend discussions with the Manager, and maintaining accurate records for released batches.

Qualifications

• Bachelor degree in (Bio-) Chemistry or Pharmacy is required.
• Experience as QA Officer/batch reviewer in pharma is advantageous.
• Proficient in Microsoft Excel; TrackWise experience is a plus.

Responsibilities

• Review batch documentation per GMP and MA requirements to ensure release suitability.
• Verify completeness and accuracy of batch documents.
• Assess end product packaging and leaflet accuracy.
• Report deviations to QP and coordinate batch releases.
• Consult with QP on prioritization and details of releases.
• Discuss process trends with the Manager and review batch documentation.
• Process documentation of released batches and monitor progress.

Skills

Multitasking

Teamwork

Cross-cultural collaboration

Education

Bachelor's degree in (Bio-) Chemistry or Pharmacy

Tools

TrackWise

Microsoft Excel

Job description

Sun Pharma is the world’s fifth largest specialty generic pharmaceutical company and India’s top pharmaceutical company. A vertically integrated business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun pharma’s global presence is supported by 50 manufacturing facilities spread across five continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2000 scientists and R&D investments of over 7% of annual revenues.

In addition to our strong position in generics, Sun Pharma is rapidly growing its Specialty / Innovative Medicines business, with a clear focus on developing and commercializing novel therapies across dermatology, oncology, ophthalmology, and other therapeutic areas. The company is making strategic investments to launch niche specialty targeting unmet medical needs.

About the role

The QA Officer is responsible for monitoring and maintaining the quality (compliance) of medicinal products and internal processes, in such a way that the EU GMP, the registration dossier, the national legislation and the client's guidelines are met.

Tasks and Responsibilities

• Review of batch documentation in accordance with the requirements of Good Manufacturing Practice (GMP) and in compliance with Marketing authorization so that each batch is suitable for release to the market
• Checking the presence and completeness and accuracy of all batch documents
• Assessing the end product for accuracy of the primary and secondary packaging and package leaflet
• Reporting to QP deviations occurred during process/testing/transport
• Consult with the Qualified Person about the prioritization and details of batches to be released
• Discussing (periodically) trends and / or specifics of the process with the Manager,
• (co) Administrative processing of the documentation of released batches
• Monitor the progress of batch documentation review and releases

Qualified candidates must have or be

• HBO or Bachelor Degree in (Bio-) Chemistry, Pharmacy or similar education
• Some work experience as a QA Officer/batch reviewer in the Pharmaceutical industry would be an advantage
• Insight into production processes and business processes
• Well versed in Microsoft Excel
• Ability to effectively manage multiple, complex priorities
• 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.
• experience with Track Wise would be an advantage