Quality Auditor
Quality Auditor
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Job Description
About PSC Biotech
Who are we
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.
Overview:
Requirements
Role Functions:
- Serve as the point of contact for quality at both the site level and with external inputs coordinating and attending Quality working group meetings.
- Participate as a functional expert in the crossfunctional team responsible for introducing products and materials at site.
- Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
- Author review and approve protocols and reports for technology transfer method qualification and method validation.
- Review documentation associated with new product and material introduction such as Material Packs QC Test Specifications BOMs and MES documentation.
- Develop and monitor supplier performance metrics participate in material review boards and quarterly reviews of key suppliers and actively engage in crossfunctional forums as needed.
- Maintain the approved supplier management list within the qualified Supplier Management system ensuring correct setup of suppliers and materials used at site.
- Support deviation and atypical closeout as well as initiate and follow up on corrective and preventive actions.
- Facilitate compliance direction for the site by adhering to divisional policies guidelines and regulatory requirements. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency. Actively participate in Plant/Quality committees and collaborate with other site functional groups.
Experience Knowledge & Skills:
- A minimum of 35 years of experience in a quality role ideally in a pharmaceutical manufacturing environment.
- Knowledge of regulatory/code requirements related to Irish European and International Codes Standards and Practices.
- Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.
- Strong report standards and policy writing skills.
- Experience with equipment and process validation.
- Familiarity with sterile filling processes and equipment.
- Proficiency in Microsoft Office and jobrelated computer applications.
- Experience or familiarity with Lean Six Sigma methodology is desired.
- Good collaboration skills and the ability to work effectively as part of a team to determine priorities.
- Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance.
- Proven ability to drive the completion of tasks.
- Strong decisionmaking capability with a sense of accountability and responsibility.
- Demonstrated problemsolving skills.
Qualification:
- A Bachelors degree or higher in a related Science discipline is preferred
#LIKV1
Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings. Participate as a functional expert in the cross-functional team responsible for introducing products and materials at site. Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities. Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
Employment Type
Full Time
