Global cGMP Remediation Expert

• 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