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 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:
Our site are excited to offer a fantastic Compliance Specialist (Validation) for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidate will provide compliance support to all areas of Validation, ensuring compliance to cGMP C regulatory requirements.
Bring energy, knowledge, innovation to carry out the following:
-
Provide compliance support for validation activities
-
Support Regulatory, Divisional and Internal audits
-
Respond to operational and business areas, ensuring compliance with cGMP C regulatory requirements
-
Accountable for compliance via documentation completion, risk assessments, closing out corrective actions and proactively highlighting any issues around compliance
-
Responsible for maintaining site Validation Master Plan
-
Generation & approval of periodic revalidation plan C report
-
Generation & approval of periodic review plan
-
Generation & approval of validation governance report
-
Generation & coordination of Annual Product Review validation chapters
-
Inspection readiness coordination C support including oversight of story board preparation and ensuring GMP compliant documents are available.
-
Review of validation documentation.
-
Investigation C RCA support.
-
Ensure compliance with the QMS, industry/company specific standards and regulations.
-
Demonstrate effective communication and interpersonal skills.
-
Proactively , consistently improve personal knowledge and capability.
-
Demonstrate an awareness of own capabilities and development needs.
-
Support continuous improvement by active participation in, and contribution to, projects and problem-solving including use of MPS processes and tools.
-
Participate in driving a high performing C inclusive culture, stimulating personal growth and development.
-
Work collaboratively to drive a safe and compliant culture
-
May be required to perform other duties as assigned
What skills you will need:
-
In order to excel in this role, you will more than likely have considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:
-
Relevant technical qualification(s) in Applied Pharmaceutical / Biological /
-
Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
-
Exception / Deviation Management and Change Control.
-
Equipment Periodic Validation
-
Equipment Validation Lifecycle
-
Project Management Skills/Qualification
-
Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence C data systems (Pi System) within a GMP manufacturing environment would be beneficial
Desirable:
-
Evidence of continuous professional development is desirable.
-
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
-
Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
-
Report, standards, policy writing skills required.
-
Equipment and process validation.
-
Sterile Fill-Finish processes and equipment.
-
Proficiency in Microsoft Office and job-related computer applications required
-
Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
-
Knowledge and experience of the below areas will be considered advantageous
-
Autoclave/SIP Sterilisation Validation
-
Dry Heat Sterilisation
-
Isolator VHP/HVAC Qualification
-
Controlled Temperature Units/Equipment Qualification
-
Validation of Tank CIP C Parts Washers for in-process components.
-
Cleaning recovery studies using TOC and swab methods.
-
CCI qualification.
-
Shipping Qualification.
-
Filter Validation.
-
Vial and Syringe Processing Technologies
