Pharmathen is one of the leading complex drug delivery and formulation developers and is among the top 50 pharmaceutical research companies in Europe. Driven by innovation, the company specializes in one of the most modern and technologically innovative sectors, developing Long Acting Injectables (LAI), Sustained Release formulations and Preservative Free Ophthalmics.
Pharmathen’s portfolio consists of over 100 products, produced at its facility in Sapes, Rodopi, approved by the US Food and Drug Administration (FDA), and at its modernized production unit in Pallini, Attica.
Pharmathen is one of the largest private investors in research and development in Greece, with steady investments of €35 million annually in the R&D sector and employs over 1,350 people from over 24 different nationalities. The company's enduring success is attributed to the passion for creativity, the ethics, and dedication of its people, who share the company's vision of making a difference in people’s lives.
Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a Data Integrity Lead for the Corporate Quality Management department at our Sapes, Northern Greece premises.
As a Data Integrity Lead you will be responsible for ensuring the accuracy, completeness, consistency, and reliability of data throughout the Quality Assurance processes by developing, implementing, and maintaining data integrity protocols and procedures to ensure compliance with regulatory standards and company policies.
More particularly:
What you will do:
- Develop and implement data integrity standards and best practices and update policies and procedures as needed to address evolving data management challenges
- Ensure data is accurate, complete, and consistent across all systems and conduct regular audits and assessments to identify and rectify data integrity issues
- Lead data integrity projects and initiatives and develop project plans, timelines, and budgets
- Create and maintain data management policies and procedures and ensure that data integrity solutions are integrated with existing systems and workflow
- Ensure compliance with regulatory requirements and industry standards; thorough knowledge or regulatory requirement and current expectations of data integrity
- Ensure adherence to the ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) principles in all data management practices
- Work closely with IT, data management, and business teams to understand data needs and challenges
- Provide training and support to staff on data integrity standards and procedures
- Serve as a point of contact for data integrity issues and inquiries
- Maintain a database of audit findings, corrective actions, and compliance metrics
- Prepare and present reports on the site’s compliance status to senior management
- Identify opportunities for improvement in the site’s quality systems and processes
- Work with data owners and stewards to resolve data quality problems
- Monitor data quality metrics and report on data quality issues
- Oversee the use of data management tools and technologies
- Follow Company's Quality Policy and comply with current operational standards and legislative requirements
- Work in accordance with the requirements of the written Policies, Standard Operating Procedures, Technical Directives and Protocols of the company's Quality System, that are related to the duties of the described position
- Follow the rules of hygiene and control of health status as defined in the relevant Policies and Standard Operating Procedures
Requirements
Minimum Qualifications
- Bachelor’s degree in Information Technology, Computer Science, Data Management, or a related field - master’s degree is a plus
Minimum Experience
- Minimum of 5-7 years of experience in data management, data quality, or a related field
- Proven experience in developing and implementing data integrity standards and procedures
Job-Specific Skills
- Strong understanding of data management principles and practices
- Proficiency with data management tools and technologies
- Excellent analytical and problem-solving skills
- Strong project management and organizational skills
- Excellent communication and interpersonal skills
- Ability to work collaboratively with cross-functional teams
- Knowledge of GAMP 5 (Good Automated Manufacturing Practice) guidelines
- Experience with Computer System Validation (CSV) processes and requirements
- Attention to Detail
- Strategic Thinking
- Leadership and Team Management
- Technical Proficiency
- Regulatory Knowledge of data integrity
- Problem Solving
Benefits
What you'll gain:
- Involvement in a high-caliber, team-oriented and dynamic atmosphere
- Exposure to challenging business issues and practices
- Great opportunity to leverage and develop your business knowledge and skills
Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.
Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.
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Last updated on Jul 3, 2024