Job description

JOIN OUR TEAM!

PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.

General Description:

We are seeking consultants who can provide support as a CSV Specialist in a pharmaceutical and biotechnology industry.

KEY RESPONSIBILITIES AND ACTIVITIES

• Preparation of risk-based CSV procedure meeting regulatory expectations addressing both retrospective and prospective validation.
• Preparation of CSV and Part 11 templates and protocols
• Assistance in categorization of computer systems
• Coordination and execution of DI system risk assessments and validations
• Preparation of associated validation reports
• Consult on the remediation actions and methods to address known gaps.

REQUIREMENTS

• Bachelor’s degree in Sciences/Engineering and at least 5 years of directly related experience on the Life Sciences industry (e.g. Pharmaceuticals, Biotechnology, Medical Devices, Cell & Gene Therapy)
• With at least 5 years experience performing CSV
• Experience working on regulatory and compliance environments
• Broad knowledge of current validation principles and industry practices including FDA and EU regulations, cGMPs, and validation guidance documents is required.

PharmaLex is an Equal Opportunity Employer.

Job Type: Contract

Education:

• Bachelor's (Preferred)

Experience:

• Computer system validation: 5 years (Preferred)
• Pharmaceutical, Biotechnology and Medical Device industry: 5 years (Preferred)

Work Location: One location

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