Demo
Job Title: Freelance Quality Assurance Consultant
Location: Germany (Hybrid)
Job Type: Freelance / Contract
Duration: 6 Months
Job Overview:
We are seeking an experienced Freelance Quality Assurance (QA) Consultant with expertise in the pharmaceutical manufacturing industry. The successful candidate will provide strategic support and guidance to our clients, ensuring that manufacturing operations meet regulatory standards and maintain the highest quality control measures. You will work closely with cross-functional teams to assess, improve, and implement effective quality management systems and processes, while ensuring compliance with all relevant industry standards, including Good Manufacturing Practices (GMP), FDA, and other global regulatory requirements.
Key Responsibilities:
Quality Assurance Systems Development:
Design and implement quality management systems (QMS) tailored to the pharmaceutical manufacturing environment.
Develop and optimize standard operating procedures (SOPs) and quality control protocols.
Establish best practices to maintain compliance with GMP, FDA regulations, and international standards (e.g., ICH, WHO, ISO).
Auditing & Compliance:
Conduct internal audits and external supplier audits to ensure compliance with regulatory standards.
Prepare for regulatory inspections and manage responses to regulatory bodies (FDA, EMA, etc.).
Assist in the preparation and review of regulatory submissions, product dossiers, and other compliance documentation.
Risk Management & CAPA (Corrective and Preventive Actions):
Identify quality risks in manufacturing processes and help implement risk mitigation strategies.
Manage investigations into non-conformances, deviations, and complaints, ensuring timely closure of CAPA (Corrective and Preventive Actions).
Provide recommendations to improve quality and reduce the risk of product recalls or non-compliance.
Training & Support:
Provide training to staff on quality assurance practices, GMP regulations, and best practices in the pharmaceutical industry.
Support the implementation of training programs to maintain a culture of quality within the organization.
Documentation & Reporting:
Review and approve batch records, production logs, validation documents, and other quality-related documentation.
Provide clear and detailed reports outlining audit findings, quality assessments, and improvements.
Continuous Improvement:
Lead or contribute to continuous improvement initiatives in manufacturing and quality systems.
Monitor the performance of quality systems and propose enhancements to achieve operational excellence.
Qualifications:
Education:
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related field (required).
Advanced degree (Master’s or PhD) in a related field is a plus.
Experience:
Minimum of 5-7 years of experience in Quality Assurance within the pharmaceutical manufacturing industry.
Proven expertise in pharmaceutical manufacturing processes, GMP, FDA, EMA, and ICH guidelines.
Experience with auditing, regulatory inspections, and CAPA management.
Knowledge of the development and maintenance of Quality Management Systems (QMS).
Skills:
Strong knowledge of industry regulations (FDA, GMP, ISO, etc.) and the ability to ensure compliance in manufacturing environments.
Excellent analytical skills with the ability to interpret complex data and provide actionable insights.
Strong project management and organizational skills.
Exceptional written and verbal communication skills, including the ability to present findings and recommendations to clients.
Ability to work independently and manage multiple projects simultaneously.
Experience with quality management software and tools is an advantage.
Personal Attributes:
Detail-oriented with a strong commitment to ensuring the highest level of product quality and compliance.
Strong problem-solving abilities, with the ability to think critically and provide practical solutions.
Flexible and adaptable to changing project needs and environments.
Excellent interpersonal skills, with the ability to work with diverse teams and stakeholders.
How to Apply:
Interested candidates should submit their resume, along with a cover letter outlining their relevant experience and approach to quality assurance in pharmaceutical manufacturing, to callum.oshea@meetlifesciences.com. Please include examples of past projects or achievements that demonstrate your ability to manage quality systems and compliance in the pharmaceutical industry.
Note: This is a freelance/contract-based position with the potential for ongoing engagements based on project needs and performance.