Job Description

About the Role:

We are looking for a highly experienced and knowledgeable individual to join our team as a Lead Auditor.
The role is 100% remote and requires a minimum of 5-10 years of experience in pharmaceutical/biotechnology, quality, or compliance roles.
The ideal candidate should have a strong understanding of cGMPs and technical aspects related to the support area.

Responsibilities:

Maintain expert knowledge of GMP requirements and industry trends.
Advise supported areas on quality requirements for projects
Independently audit regulatory filings and ensure compliance
Identify training needs and conduct training sessions for staff
Develop SOPs to ensure accurate practices
Represent GMPQ on cross-functional teams and provide quality guidance Prioritize activities for multiple projects
Support preparations for regulatory agency inspections

Education Qualification:

B.S., M.S., and/or PhD. degree in an appropriate Science or Engineering discipline.

Required Skill:

Effective communication, negotiation, problem-solving, and interpersonal skills.
Project management abilities.
Experience in computer science, IT, quality assurance, auditing, or regulatory submission requirements.
Ability to foster collaboration, drive results, and make rapid disciplined decisions.
Strong organization skills and ability to manage multiple projects.
Clear and concise communication skills.
Interpersonal skills to effectively lead an auditAbility to prioritize audit sections based on CMC request.
Track record of meeting deadlines and maintaining audit goals.
Experience in providing technical guidance and support for process improvement initiatives.

Recruiter

Phone

Rohan Lazarus

rohan.lazarus@collabera.com

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