Compliance Engineer

Job Description 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 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).
  #LI-DM2 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).
#LI-DM2