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 PropositionEmployees 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.Overview:Responsible for ensuring that the process for the
manufacture of drug product at our site is in compliance with cGMP and the
associated regulatory requirements. Responsible for reviewing and approving GMP
documentation to support corporate compliance/regulatory expectations for
manufacturing operations. Ensure that objectives are effectively achieved,
consistent with client's requirements to ensure compliance, safety and reliable
supply to our customers.For Applicants, it is important to note that
this will be a Shift IPT Role. The Shift pattern will be discussed in
interview, as patterns of shift will differ at project stages/s.RequirementsPrincipal Accountabilities: Documentation:Review and approval of all manufacturing batch
documentation including electronic batch records, real time reports, master
data using the site systems.Review and approval of SOP's, cleaning
verification/validation data and other documents as necessary for the IPT
department.Drive effective writing/revising/ rolling out of accurate
operational procedures, training materials and maintenance procedures for
various Quality related systems; ensure all work is subsequently carried out in
line with same.Support the development and implementation of improved
quality reporting measures.Liaise with the Quality Specialists/QP/QA Lead to resolve
queries relating to batch manufacturing process. Quality Oversight:Work collaboratively to drive a safe and compliant
culture.Work shift patterns in line with manufacturing operations
to ensure Quality oversight as required.Provide effective real time on the floor support for day
to day manufacturing operations for example area clearances, batch record
reviews, aseptic operations.Provide quality input into decision making process on the
shopfloor ensuring that product quality is maintained.Provide training in all aspects of Quality Management
Systems and GMP.Ensure all work is carried out in line with SOP’s,
training or other quality systems such as change controls where applicable.Facilitate compliance direction for the site by assisting
in the adherence to divisional policies and guidelines as well as regulatory
requirements.Identify and facilitate major compliance initiatives to
improve compliance status and overall operational efficiency of the site.Actively participate in Plant/Quality committees and
works with other site functional groups, such as the Microbiology Laboratory,
Production, Utilities, Site Services, and Maintenance to help set direction for
plant wide GMP initiatives.Drive compliance 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.Aid the effective implementation of the Quality
Management System and facilitate the continuous improvement of same ensuring
the Quality Management Systems are accurate and complete; review on a
continuous basis. Be an advocate of continuous improvement in the Quality
Management Systems. Continuous Improvement:Partner with colleagues cross functionally to provide
support and advice on day to day basis and on a project basis including
communications, training, project work, audit/inspection duties,
investigations, batch work, customer queries etc.; thereby ensuring IPT is
audit/inspection ready. Conduct area inspections for IPT as appropriate.Initiate and maintain Quality related metrics, ensuring
effective communication and follow up of same. Such ongoing monitoring/metrics
gathering may include:Monitoring of quality systems,The self-inspection program,Verification of the effective implementation of key GMP
programsEffectiveness of Preventative ActionsLeadership activities including selection, development,
coaching, and day to day management. Ensure that the team receives appropriate
resources and programs to develop technical and other skills, to complete their
jobs whilst stimulating personal growth and development in line with role.
Develop and maintain training programs.Required to comply with client Global and regulatory
requirements and execute current Good manufacturing Practices (cGMP) in the
performance of day to day activities and all applicable job functions.Work collaboratively to drive a safe and compliant
culture.May be required to perform other duties as assigned. Skills and Knowledge:Third Level Degree qualified in a Science/Technical or
related discipline.Relevant experience in a quality role, ideally in a
pharmaceutical manufacturing environment.Knowledge of US and European cGMP guidelines, and other
international regulatory requirements, as applicable to the site.GMP Audit experience in the pharmaceutical industryProblem-solving / critical thinking – ability to
understand connections between different technical/quality system areas and
recognize potential compliance issues and trends.Communication, decision making, people influencing, and
project management skills will be important.Report, standards, policy writing skills required.Demonstrated ability to make and act on decisions while
balancing speed, quality and risk.Ability to provide innovative ideas to improve quality
and compliance that create value including seeking new information and external
insights.#LI-DM2