R

Change Control Manager

remedica • Greece
Relocation
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AI Summary

Manage the end-to-end lifecycle of Change Report Forms (CRFs) within the Quality Management System. Responsible for cross-functional collaboration, regulatory compliance, and maintaining change control records for GMP compliance. Requires a Bachelor's degree, 5+ years in pharma/biotech, and 2-3 years in quality systems management.

Key Highlights
Oversee the entire lifecycle of Change Report Forms (CRFs).
Ensure regulatory compliance and GMP standards.
Drive process improvements and data analysis for quality initiatives.
Key Responsibilities
Manage the lifecycle of all assigned Change Report Forms from initiation through evaluation, review, approval, and closure.
Coordinate cross-functional change controls, ensuring resources are allocated to implement them accordingly.
Track Change Report Forms progress and proactively follow up with stakeholders to ensure timely completion of actions.
Review change control reports for completeness, accuracy, technical adequacy, and regulatory compliance.
Verify Change Report Forms are appropriately performed and documented.
Ensure suitable Corrective and Preventive Actions (CAPAs) are identified, implemented, and assessed for effectiveness, if applies.
Maintain oversight of CRF-related performance metrics and present status updates to management.
Support regulatory inspections, customer audits, and internal audits by providing quality records and investigation documentation.
Identify recurring trends and systemic issues through data analysis and recommend improvement initiatives.
Ensure compliance with GMP, data integrity requirements, internal procedures, and regulatory expectations.
Participate in the development of the quality procedures related to change control system.
Prepare management reports and quality performance dashboards as required.
Technical Skills Required
Quality Management Systems GMP Compliance CAPA Management
Benefits & Perks
Relocation support
55,407.00 EUR - 83,111.00 EUR gross annually
Nice to Have
Master's degree in a relevant field
Experience with eQMS platforms, document management systems, and investigation tracking tools

Job Description


Why REMEDICA

Remedica is a leading pharmaceutical company with a vision for a healthier world through high quality, safe and efficacious products at affordable prices.


Job Purpose:

The purpose of this position is to manage and oversee the end-to-end lifecycle of Change Report Forms (CRFs) within the Quality Management System.

The role is responsible for driving cross-functional collaboration, monitoring key performance indicators, ensuring regulatory compliance, identifying process improvements, and maintaining the integrity, accuracy, and completeness of change control records to support GMP compliance and continuous improvement initiatives.


This position is based in Limassol. The company offers relocation support for candidates who are considering moving to Cyprus.


Duties & Responsibilities:

  • Manage the lifecycle of all assigned Change Report Forms from initiation through evaluation, review, approval, and closure.
  • Coordinate cross-functional change controls, ensuring resources are allocated to implement them accordingly.
  • Track Change Report Forms progress and proactively follow up with stakeholders to ensure timely completion of actions.
  • Review change control reports for completeness, accuracy, technical adequacy, and regulatory compliance.
  • Verify Change Report Forms are appropriately performed and documented.
  • Ensure suitable Corrective and Preventive Actions (CAPAs) are identified, implemented, and assessed for effectiveness, if applies.
  • Maintain oversight of CRF-related performance metrics and present status updates to management.
  • Support regulatory inspections, customer audits, and internal audits by providing quality records and investigation documentation.
  • Identify recurring trends and systemic issues through data analysis and recommend improvement initiatives.
  • Ensure compliance with GMP, data integrity requirements, internal procedures, and regulatory expectations.
  • Participate in the development of the quality procedures related to change control system.
  • Prepare management reports and quality performance dashboards as required.


Qualifications and Skills:

  • Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Biotechnology, Biology, Quality Management, Engineering, or a related scientific discipline.
  • Master's degree in a relevant field is considered an advantage
  • Minimum 5 years of experience within a pharmaceutical manufacturing, biotechnology, or regulated healthcare environment.
  • At least 2-3 years of experience managing quality investigations, deviations, CAPAs, complaints, or quality systems.
  • Demonstrated experience coordinating cross-functional projects and stakeholders.
  • Strong collaboration and relationship-building skills.
  • Effective conflict resolution and stakeholder management capabilities.
  • Strong customer and quality-focused mindset.
  • Excellent written and verbal communication skills.
  • Ability to prepare technical reports and executive summaries.
  • Strong presentation and facilitation skills.
  • Fluent in English (written and spoken).
  • Proficient in Microsoft Office Suite, particularly Excel, Word, PowerPoint, and Power BI.
  • Experience with eQMS platforms, document management systems, and investigation tracking tools.
  • Ability to analyze quality data and prepare management reports.


Salary Range:

Minimum Pay:55,407.00 EUR gross annually

Maximum Pay: 83,111.00 EUR gross annually



If you are interested you can apply via our website: Change Control Manager Job Details | Remedica Limited


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