Work location - Amsterdam, Netherlands (Remote)
Major Activities / Tasks
I. Monitor manufacturing of batches hence ensuring overall manufacturing compliance
• Drive processes as per the requirements specified in the national laws of the country or EU
• Requirements of Marketing authorization
II. Schedule and manage overall specifications as described in the guidelines of each batch imported to the community.
• Drive and monitor quantitative and qualitative analysis of products imported from outside the EU in accordance with the requirements of the Marketing Authorization
Quantitative
• Review and evaluate the release of necessary certificates as per EU guidelines
• Plan, implement and track release of necessary amount of reference stored samples stored for each batch of products
• Monitor validations of manufacturing and quality control testing processes
• Helping resolve the product issues for EU market, by working with cross functional teams both IH & IL products
III. Implement and maintain Registers or equivalent document of overall operations.
• Implement and track certifications in register or equivalent for product release or sale in EU market
• Maintain records such as Quality Management Review, Annual Product Review reports, relevant deviations,
CAPA’s, Risk Assessments, change controls, Self- Inspections etc.
• Evaluate the validations of necessary Quality agreements with third parties as per GMP compliances
IV. Drive, monitor and control Quality system of the company in compliance with regulations and company legal framework
• Drive as single point of contact for quality and compliance questions, issues and product recalls
• Monitor, control, resolve and track all applicable Corporate Quality and Compliance Policies, procedures and requirements are implemented and specific local requirements are met
• Plan, drive and track all affected employees for necessary guidelines/SOP trainings and verifying efficiency from time to time
• Driving clear SOPs, for Quality activity for Europe – with current guidelines.
V. Review, evaluate and guide management on manufacturing and other factors that impede or effect products and patients’ health
• Abreast with the developments happening in effected legal and regulatory environments of company and EU
• Plan, track and present issues, concerns, developments on-time to management for necessary corrective and preventive actions
• Support EURA to liaise with MHRA for Mfg. lines and product approvals.
VI. Will act as QP (Qualified Person) for Cipla EU Limited
post QP application approval
• Will act as QP (Qualified Person) for Cipla EU Limited post QP application
Key Skills & Qualifications
Regulatory Knowledge:
A deep understanding of pharmaceutical regulations and evolving guidelines.
Technical Expertise:
A solid foundation in pharmaceutical manufacturing, quality control, and quality assurance.
Experience:
Extensive practical experience at least for 5 years in the pharmaceutical industry as QP.
Problem-Solving:
Strong ability to identify, investigate, and resolve quality-related problems.
Communication:
Effective communication skills to collaborate with various departments, business partners, and regulatory bodies.
Legal Responsibility:
A commitment to taking on the significant legal responsibilities associated with batch certification and quality oversight.
Qualification - Bachelor / Masters in Science or Pharmaceutical
Reporting to – Quality Leadership Group at UK
Job Location - Remote