Enable America Jobs

Description:

GMP –

• Minimum 5+ years of external Vendor Audit Leadership – RECENTLY in the past 5 years, they have been responsible for being the lead auditor for vendor audits preferably.

• 3 of the recent 5 years needs to be within Pharma due to recent regulation implementation they must to up to speed

• Fluency in subsystems of GMP Audits – facilities and equipment auditing (training staff; validation of equipment/systems; etc) ; materials auditing; production audit; Packaging and labeling; laboratory controls (ie batch release; sterilization)

GVP --

• Minimum 5+ years RECENT experience of external Vendor Audit Leadership with specialization in PV – leading the way with audit scheduling, audit prep, plan and execution as well as report completion and follow up (not the supporting auditor who just takes on tasks given to them)

• Fluency (5+ years’ experience) in reviewing pharmacovigilance systems that focus on collection, processing and submission of adverse events, Writing aggregated reports, signal and risk management reports.

• Ideal experience would be commercial pharmacy; Safety review of device or drug

GLP –

• Minimum 5+ years of RECENT experience external Vendor Audit Leadership – meaning RECENTLY in the past 5 years, they have been responsible for being the lead auditor for vendor audits preferably.

• Fluency in review and audit of SOP systems; study plan/report build; method validation; excellent understanding of lab key personnel qualifications (ie Chemist; Study Director etc)

• Understanding of Computer system validation auditing when applied within the laboratory setting

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.