Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
We are looking for a highly skilled pharma-GMP auditor and risk management leader. This leader will have a significant amount of quality auditing experience across diverse technologies, working with systems-based audit approaches that cover all aspects of pharma-GMP systems. We emulate a high degree of integrity, depth and accuracy in our approach, with a dedication to carrying out a premier audit program.
Description of the role:
We identify systemic gaps in quality/compliance by conducting internal audits of Thermo Fisher Pharma Services Group (PSG) manufacturing and Clinical Trial Division (CTD) sites. We prepare detailed audit reports to communicate observations written in a meaningful and accurate way, so that readers can easily understand the conditions or gaps in compliance with regulations and quality compliance standards.
We maintain knowledge of GMPs and are routinely aware of revised or emerging quality regulations and their trends, as well as industry methodologies across the globe.
We promote positive Quality and leadership behaviors such as: creating environments for learning, harnessing lessons learned to drive continuous improvement; sharing standard methodologies; maintaining effective and open communication; and encouraging cross-functional partnerships.
We also participate in ad-hoc quality compliance projects related to auditing (e.g. detailed trending reports, data analysis, reviewing global PSG policies, and preparing auditor training materials for internal/external quality auditors in the PSG network, etc.).
How you will make an impact:
Becoming a key player in the mission to holistically assess the state of quality and regulatory compliance across PSG global manufacturing/testing sites via fully independent audit program.
Helping to minimize risk across the sites and achieve successful regulatory inspections.
Making a contribution toward the success of PSG and the services/products provided to clients and patients.
How will you get here?
Minimum of 10 years professional working experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC, Regulatory or related compliance experience with at least 5 years aggregate experience performing audits for GMP, ISO or ICH, and hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections.
Knowledge, Skills, Abilities:
Must be an expert Quality compliance auditor.
Experience with elements of data integrity covering all areas in a pharmaceutical manufacturing environment, including production and QC laboratories, is also crucial, as well as being skilled in quality investigations, root cause analysis, audit reporting and benchmark sharing with a commitment towards quality improvement. Experience in sterile manufacturing and aseptic practice is desired.
Professional auditor training/certification by an organization recognized within the pharmaceutical industry (e.g. IRCA, ASQ).
Strong foundation of pharmaceutical manufacturing and laboratory operations.
Diverse experience auditing a wide range of manufacturing technologies and services in 30% or more of the following areas:
- Sterile drug products: (liquid, lyophilized vials, prefilled syringes)
- Non-sterile drug products: (tablets, powders, capsules, granules, softgels)
- Biologics cell culture: upstream (Fed-Batch, Perfusion, XD, etc.) and downstream purification processes (Chromatography, nano filtration, etc.)
- Chemicals, intermediates, API manufacturing: (synthesis, purification, drying, isolation, etc.)
- Packaging operations: (primary and secondary)
- QC laboratories (Analytical and Microbiological)
- IT / Computer systems validation
- Clinical and commercial stage products and services
- Viral vector (VVS) and microbial manufacturing (MMS)
- Data integrity audits: (both laboratory and non-laboratory operations)
Strong communication skills including listening, judgment, problem management, ability to lead teams in a sophisticated and global environment.
Ability to anticipate potential problems and risks related to quality system / regulatory expectations including ability to formulate and implement solutions.
Strong collaboration and problem-solving skills; and adept at working well within a team environment.
Capable to conduct remote auditing, when required.
Strong oral/written communication skills appropriate for diverse international collaboration including excellent fluency in English.
Education
Bachelor’s Degree in Pharmacy, Science or Engineering. Advanced degree in related field preferred.
Location: Remote
Must be able to travel 40% based on business needs.
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