QualificationValidation Specialist in GxP
QualificationValidation Specialist in GxP
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Job Description
GMS is an operational consultancy with expertise in data and digital systems. Whether digitalisation data & analytics or compliance our consultants are the missing piece of our customers digital puzzle. We empower their ongoing digital transformation and transform challenges into opportunities. Were part of the MoOngy Group a more than 18 years old European network of companies with a focus on IT & Engineering expertise.
Tasks
What we are looking for:
Position: Qualification/Validation Specialist in GxP
Location: Frankfurt RhineMain Area
Type: Full remote Hybrid position
As a Qualification/Validation Specialist you will be responsible for ensuring that all equipment systems and processes within our GxPregulated environments are qualified and validated according to industry standards. You will play a key role in maintaining compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines contributing to the overall success and quality of our operations.
Requirements
- Bachelors degree in Chemistry Biochemistry Pharmaceutical Sciences or a related field.
- 23 years of experience in validation and qualification of equipment in a GxPregulated environment
- Strong knowledge of GMP GAMP 5 and other regulatory requirements.
- Experience with validation documentation including writing and reviewing validation protocols and reports.
- Familiarity with risk management tools (e.g. FMEA) and approaches in validation.
- Ability to work collaboratively in crossfunctional teams and manage multiple projects simultaneously.
- Strong organizational communication and problemsolving skills.
- Attention to detail and a commitment to maintaining high standards of quality and compliance.
- Prior experience in a Germanspeaking GxP environment (mandatory)
- Experience with computer system validation (CSV) and IT system qualifications (is a plus)
- Native in German (mandatory)
- Residency in Germany with the ability to work in a hybrid model from Frankfurt RhineMain Area
Your tasks as Qualification/Validation Specialist in GxP:
- Perform Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) for equipment and systems in compliance with GxP guidelines.
- Conduct process validation and equipment qualification activities to ensure that all manufacturing laboratory and IT systems meet regulatory requirements.
- Develop and review validation protocols reports and standard operating procedures (SOPs).
- Collaborate with crossfunctional teams including Quality Assurance (QA) Engineering and Production to ensure smooth validation processes.
- Perform risk assessments to identify potential risks and implement appropriate controls to mitigate those risks.
- Maintain thorough documentation of all qualification and validation activities in compliance with GxP standards.
- Ensure adherence to GAMP 5 GMP and other relevant regulatory requirements during all validation projects.
- Support internal and external audits by providing validation documentation and addressing any queries related to validation activities.
- Monitor and address any deviations nonconformances or changes in validated systems and processes.
Benefits
What you get from us
- We are a growing company with ambitious targets that stands for expert knowledge integrity and openmindedness.
- As a consultant you will implement a wide range of projects for our wellknown customers and offer them your growing expertise
- Your development is supported by a coach further training our inhouse learning platform and an internal IT & data network
- Worklife balance is important to us you enjoy home office options have the choice between regional or Germanywide projects and our philosophy is a 40hour week
- We also offer security and stability our employees are employed on a permanent basis
At GMS we defend equality and diversity. We create a safe and diverse environment where all the opportunities are equal for all the employees. We do not discriminate based on age ethnicity sexual orientation gender disability or any factor other than merit. All applications with skills for the position are welcome! Would you like to apply with us Then we look forward to receiving your CV.
Employment Type
Full Time
