Quality Assurance Consultant

il y a 2 semaines


Paris, Île-de-France Meet Temps plein

Job Title: Freelance Quality Assurance Consultant

Location: Remote/On-site

Company Overview:

Our client is a leading pharmaceutical manufacturing company dedicated to producing high-quality, life-saving products. They are seeking a highly skilled and experienced Freelance Quality Assurance (QA) Consultant to help ensure the highest standards of quality and compliance in their operations. The ideal candidate will possess deep expertise in pharmaceutical manufacturing and regulatory compliance, with a strong ability to assess and enhance quality systems.

Job Type: Freelance / Contract (Duration: 6 months, 1.0 FTE)

Key Responsibilities:

  1. Quality Systems Review & Enhancement: Conduct thorough assessments of the company's existing quality management systems (QMS) to ensure compliance with industry regulations and standards (FDA, EMA, cGMP, etc.). Provide actionable recommendations for process improvements, risk management, and documentation practices.
  2. Regulatory Compliance Support: Advise on best practices for maintaining compliance with regulatory bodies. Support in preparation for audits, inspections, and regulatory submissions. Ensure that products meet the necessary regulatory requirements and quality standards.
  3. Process Validation: Review and validate manufacturing processes to ensure they meet established quality specifications. Provide support for process qualification, including writing and reviewing protocols and reports. Identify quality risks in production, supply chain, and distribution. Assist in the development and implementation of risk mitigation strategies, ensuring proactive quality controls are in place.
  4. Training & Development: Develop and deliver training sessions to staff on quality assurance best practices, regulatory changes, and compliance. Help to foster a culture of continuous improvement in the workforce.
  5. Audit & Inspection Support: Lead or support internal and external audits, inspections, and regulatory filings. Review audit findings and work closely with the team to implement corrective and preventive actions (CAPAs).
  6. Documentation Review: Review and approve batch records, SOPs, testing protocols, and other key documentation to ensure accuracy and compliance with regulatory standards.

Qualifications:

Experience: Minimum of 10 years of experience in Quality Assurance within the pharmaceutical or life sciences industry, with hands-on expertise in manufacturing environments.

Education:

  • A bachelor's degree in pharmacy, Life Sciences, Chemistry, or related field. Advanced degree (master's or PhD) is a plus.
  • Relevant certifications such as Certified Quality Auditor (CQA), Certified Pharmaceutical GMP Professional (CPGP), or equivalent are preferred.

Skills:

  • In-depth knowledge of cGMP, FDA, EMA, and other global regulatory guidelines.
  • Proven experience with quality risk management, CAPA systems, and validation processes.
  • Strong ability to analyse and solve complex quality issues.
  • Excellent communication skills and the ability to interact with cross-functional teams.
  • Detail-oriented with a commitment to delivering high-quality results.
  • Ability to work independently with minimal supervision, managing multiple projects and deadlines. Strong analytical and problem-solving skills. Flexibility to adapt to varying project requirements.

Preferred Experience:

Prior experience working as a consultant in a freelance capacity (willing to consider Permanent Consultants wishing to move to Freelance). Familiarity with pharmaceutical manufacturing equipment, testing methods, and product development cycles.

Why work with us?

Meet offer all our Freelancers competitive compensation based on experience and deliverables, as well as the flexibility to work on-site, remote, or hybrid (depending on the needs of the project). What makes us different is that we offer a consultative approach to our Freelancers, regularly checking in to ensure we are meeting your expectations.

How to Apply:

Please submit your resume, along with a cover letter highlighting your relevant experience and availability, to callum.oshea@meetlifesciences.com

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing and Biotechnology Research

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