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Pharmaceutical Quality Assurance Auditor
2 months ago
Position Summary
Are you dedicated to ensuring excellence in the life sciences sector? Do you aspire to collaborate with esteemed organizations in pharmaceuticals, biotechnology, veterinary health, and other regulated fields? If you possess a keen attention to detail and are committed to enhancing quality of life, this position may be ideal for you.
Role Expectations:
As a member of a global quality auditing team, you will play a crucial role in maintaining quality standards within the supply chains of our clients across the pharmaceutical, medical device, cosmetics, biologics, and animal health sectors. Operating within your designated region, you will liaise with SQA's operations center to coordinate, prepare, execute, and deliver supplier quality audits in accordance with client audit schedules. You will collaborate with SQA's distinguished production team to align your expert findings with the specific structure and guidelines of each client's managed audit program.
Key Responsibilities:
Your primary responsibility will be to conduct quality audits at suppliers for SQA's clients. Each client presents unique program requirements, and you will be oriented accordingly during your onboarding process for each program. Utilizing your skills and experience, you will produce consistent results that facilitate the seamless integration of audit findings into each client's supplier risk management framework.
Qualifications:
Expertise in US FDA Pharmacovigilance regulations is essential. You should have experience managing pharmacovigilance agreements with multiple stakeholders and demonstrate assertiveness when dealing with challenging auditees.
As an SQA Quality Auditor, a minimum of four years of relevant experience is required, and you will be assigned based on your subject matter expertise in relation to the manufacturing environment. You should possess in-depth knowledge of specific commodities and tools. Additional audit projects may be available depending on your skill set (e.g., 21CFR 210/211, 21 CFR 820, ICH guidelines, 21 CFR 58, 21 CFR 11).
Strong proficiency in English, including speaking, reading, and writing, is necessary, along with a willingness to travel regionally.
Compensation:
The pay range is $ USD for a one-day audit, which encompasses time spent preparing for the audit, traveling, conducting the audit, drafting the report, and addressing inquiries from our editorial Content team and the client until the report is finalized. Please note that follow-up on CAPA for any findings or reimbursement for travel expenses is not included; expenses are reimbursed at cost with receipts per SQA travel policy. SQA will assist with audit preparation and provide proofreading for all audit reports.
Company OverviewSQA Services is a premier consulting firm specializing in Supply Chain and Quality Assurance. We focus on managing Supplier Audit, Quality Engineering, Inspection, and Remediation programs across various industries, including Aerospace/Defense, Semiconductor, Medical Device, Pharmaceutical, Cosmetic, and Automotive manufacturing. Our clients benefit from our extensive network of quality professionals in over 50 countries, serving as an extension of their own supplier quality teams.
