Global cGMP Remediation Expert

Posted 1 day 2 hours ago by Pharmalliance Consulting Ltd

Permanent
Not Specified
Other
Not Specified, Ireland
Job Description
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 5+ years
  • City Global
  • Province Global
  • Postal Code Global
About Us

Pharmalliance offers expert support to pharmaceutical companies to maintain and increase quality compliance levels.

We specialize in cGMP Compliance, Remediation and Contamination Control and have a suite of services to help you stay compliant no matter what your stage of development.

Job Description

This posting is an invitation to apply to join a critical remediation project. curated pool of experienced GMP professionals who will be invited to support future global remediation projects.

Pharmalliance Consulting Ltd has a global network of experienced specialists who can assist pharmaceutical, biotechnology, ATMP, and cosmetic manufacturers in addressing regulatory compliance challenges.

Experts in the network may support projects related:

  • FDA Warning Letters
  • Regulatory inspection observations (FDA, EMA, MHRA and other authorities)
  • cGMP remediation programs
  • Quality system remediation
  • Data integrity remediation
  • Validation and facility remediation
  • Inspection readiness programs

Assignments are typically contract-based consulting engagements, often involving onsite deployment globally, depending on project requirements.

Typical remediation activities may include:

  • Performing cGMP gap assessments
  • Developing remediation strategies and quality remediation plans
  • Supporting implementation of corrective actions
  • Conducting mock inspections and inspection readiness assessments
  • Supporting contamination control and sterility assurance programs
  • Supporting validation and quality system improvements

Experts may specialize in areas such as:

  • Quality Assurance (QA)
  • Quality Control (QC)
  • Microbiology / Sterility Assurance
  • Manufacturing / Operations
  • Process Engineering
  • Validation (CQV, Cleaning, Process)
  • Data Integrity
  • Utilities (HVAC, WFI, Clean Steam)
  • ATMP / Cell and Gene Therapy Manufacturing
  • Non-Sterile Pharmaceutical Manufacturing
  • Cosmetic GMP
  • Oral Solid Dose (OSD) Manufacturing
Requirements

Candidates joining the Pharmalliance Remediation Expert Network should typically have:

Experience
  • Minimum 8+ years experience in pharmaceutical, biotechnology, ATMP, or cosmetic manufacturing environments
  • Experience working within cGMP regulated environments
  • Experience supporting regulatory inspections or remediation programs
  • Experience working within at least one technical or quality discipline within GMP manufacturing
Regulatory Knowledge

Working knowledge of global regulatory frameworks such as:

  • FDA cGMP regulations (21 CFR 210/211)
  • EU GMP (EudraLex Volume 4)
  • Annex 1 - Sterile Manufacturing
  • ICH Q9 - Quality Risk Management
  • ICH Q10 - Pharmaceutical Quality Systems
Professional Skills
  • Strong problem-solving and risk-based decision-making ability
  • Experience working in cross-functional technical teams
  • Ability to identify and prioritize cGMP compliance risks
  • Strong technical communication and documentation skills
Availability
  • Willingness to participate in contractconsulting assignments
  • Availability for onsiteproject deployment globally whenrequired

Members of the Pharmalliance Global Remediation Expert Network receive several professional benefits:

Priority Project Opportunities
  • First notification of upcoming and active global cGMP remediation projects
  • Priority consideration for contract consulting engagements
Professional Network
  • Invitation to join the Private Pharmalliance Global GMP Experts LinkedIn Group
  • Collaboration with experienced remediation professionals worldwide
Free CPD-Certified Training
  • Network members receive complimentary access to Pharmalliance CPD-Certified training programs, including:
  • Cosmetic GMP Compliance
  • Oral Solid Dose (OSD) Manufacturing
  • + more
Access to Pharmalliance Experts and Resources
  • Network members get full access to other members and access to our library of knowledge, tools, templates, policies, procedures and AI Copilots when executing projects.
Industry Insights
  • Access to regulatory updates and compliance resources
  • Participation in expert knowledge-sharing initiatives and professional development opportunities