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 cloud-based 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 like-minded 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 diverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house 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.
Role Description:
The Quality Specialist will perform an integral role in the Engineering team .
They will work within a small team that will be mainly
responsible for compliance aspects within the Engineering CoE team. This will
include but not limited to the completion of investigations, generation and
management of change controls and supporting the IFM Compliance and EHS
Engineer as required.
Requirements
Role Functions:
- Support Engineering activities through documentation
generation, equipment and process investigations associated with GMP activities
and completion of quality notifications.
- Be a document system expert; this will include document
review, approval and document system work flow expedition. Format, write,
deliver and review necessary documentation in line with the standard approval
process, and facilitate others to do so. Documents will include SOP’s, SWI’s,
training documents, and change controls.
- Raise CAPA's and conduct investigations. Raise and
investigate quality notifications using standard tools and methods, to resolve
system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent
corrective action through the change management system.
- Required to comply with client Global Policies, Procedures
and Guidelines, regulatory requirements and execute current Good manufacturing
Practices (cGMP) in the performance of day to day activities and all applicable
job functions.
- Support and lead Internal Quality audits of Engineering
Dept.
- Assist in the management and/or assignment of Engineering
training if required
- Work collaboratively to drive a safe and compliant culture
in Carlow.
- May be required to perform other duties as assigned.
Experience, Knowledge & Skills:
General:
- Demonstrating energy and enthusiasm, the Quality Specialist,
will be a role model for operational excellence, and will contribute to the
departments overall capability to thrive and grow.
- Proven track-record in delivering results in a world-class
supply organisation.
- A strong career history in pharma (ideally working in a
clean utilities and/ or compliance environment) and familiarity with a highly
regulated environment.
- Innovative thinker, with excellent decision-making and
problem-solving skills.
- Experience of working in a cross functional environment.
- Knowledge of and experience in applying Six Sigma and Lean
methodologies.
- Positive, flexible action-oriented attitude.
Technical:
- Experience in Compliance systems such as IPI, SAP etc a
distinct advantage
- Knowledge of regulatory/code requirements to Irish, European
and International Codes, Standards and Practices
- Report, standards, policy writing skills required
- Proficiency in Microsoft Office and job related computer
applications required
- Lean Six Sigma Methodology experience desired
- Experience working within an Engineering environment in a
regulated industry a distinct advantage
People:
- The desire to continuously learn, improve and develop.
- Excellent communication, presentation and interpersonal
skills, to interface effectively with levels of colleagues and with external
customers in a team orientated manner
- Excellent training, facilitation and assessment skills
- Demonstrable analytical and systematic problem solving
skills
- Strong influencing skills
- Flexible approach
- Effective time management and multi-tasking skills
- Proven organizational skills
- Excellent attention to detail
- Trouble shooting skills
- Goal/results orientated
Qualifications & Education:
- Degree qualification or equivalent Min Level 7 (Science,
Engineering, Technical).
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