Responsibilities:
- Supports the client's site GMP buildings Environmental Monitoring Process.
- Generates Environmental Monitoring and Critical Utilities trend reports.
- Participates and or Leads Risk Assessments to evaluate sampling sites for routine monitoring of GMP areas.
- Provides assessments to change control records, deviations, audit processes that need support form the Environmental Control perspective.
- Participate in forums such as the Environmental Control Network, Aseptic Council and or Contamination Control Network as assigned.
- Attends client's GMP Buildings Quality system forums and or Management Review meetings to present environmental and critical utilities data and recommend actions based on the data evaluation.
- Ensures that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP practices and other applicable regulations.
- Supports Continuous Improvement initiatives, programs, and projects.
- Collaborates cross functionally as needed to ensure the Quality Management System processes are performed in alignment with established procedures.
- Alerts senior management of quality, compliance, supply, and safety risks.
- Supports internal/external audits and inspections as needed.
Qualifications:
- Bachelor's in sciences with concentration in any science discipline such as Engineering, Biology, Chemistry, Physis, Computer, etc.
Quality Professional with extensive experience in Validation, Commissioning, and Qualification (IQ/OQ/PQ) of manufacturing equipment and laboratory instrumentation, including functional testing.
Strong expertise in Technical Writing and preparation, review, and approval of GMP technical documentation, including validation reports, technical reports, procedures, protocols, and forms.
Experienced in Quality Systems, including Deviations, Change Controls, CAPAs, and GMP documentation management.
Knowledgeable in Maintenance Systems, including Preventive Maintenance (PM), Work Orders, and Job Plan review and approval.
Proven experience in Process Validation and Cleaning Validation documentation review and approval, ensuring compliance with GMP and regulatory requirements.
Strong understanding of cGMP, FDA regulations, and industry best practices for validation and quality compliance.
Skills Required
- Bachelor's degree in a science discipline (Engineering, Biology, Chemistry, Physics, Computer, etc.)
- Extensive experience in Validation, Commissioning, and Qualification (IQ/OQ/PQ) of manufacturing equipment and laboratory instrumentation
- Strong expertise in technical writing and preparation, review, and approval of GMP technical documentation (validation reports, procedures, protocols, forms)
- Experience with Quality Systems including Deviations, Change Controls, CAPAs, and GMP documentation management
- Knowledge of Maintenance Systems including Preventive Maintenance, Work Orders, and Job Plan review and approval
- Proven experience in Process Validation and Cleaning Validation documentation review and approval
- Strong understanding of cGMP, FDA regulations, and industry best practices for validation and quality compliance
- Experience supporting environmental monitoring programs and generating related trend reports
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
