Quality Auditor

About PSC Biotech

Who we are

PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

Job Title: Quality Auditor

Role Description:

The role will support validation and qualification activities and will liaise with technical subject matter experts to ensure that equipment in use on site is validated and revalidated per global and local procedures and maintains compliance.

Requirements

Role Functions:

Responsible for helping to ensure that the validated equipment on site maintains validated status.

Act as quality support for validation and qualification activities of equipment facilities and associated processes on site to ensure they are maintained in accordance with global and local procedures.

Ensure that quality issues are identified addressed and resolved in a timely manner.

Responsible for supporting deviation close out and initiating/following up on corrective and preventative actions.

Partner with colleagues cross functionally to provide support and advice on daytoday basis and on a project basis including communications training project work audit/inspection duties investigations etc.

Experience Knowledge & Skills:

Demonstrated ability in pharmaceutical equipment validation/qualification or quality support for same

Knowledge of EU/US quality related pharmaceutical regulations

Experience of Sterile manufacture preferred.

Ideally a minimum of 3 years experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality and/or engineering roles

Knowledge of regulatory/code requirements to Irish European and International Codes Standards and Practices requirements.

Knowledgeable in Industry Best Practices for quality and compliance related topics

Proven ability to effectively initiate and drive change.

Strong verbal and written communication skills project management skills

Report standards policy writing skills required.

Proficiency in Microsoft Office and jobrelated computer applications required (electronic validation systems)

Good Collaboration Skills

Ability to work as part of a team to determine priorities.

Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.

Demonstrated ability to drive the completion of tasks.

Proven decisionmaking capability with accountability and responsibility.

Demonstrated ability to solve problems.

Qualifications & Education:

Bachelor s degree or higher preferred; ideally in a related Science discipline

Lean Six Sigma Methodology experience desired.