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:Performs QC assignments for quality systems, processes and controls.Accountable for contribution to ensure that objectives
are effectively achieved, consistent with requirements to ensure compliance,
safety & reliable customer supply.Responds to Operational and business area’s, ensuring
compliance with cGMP and corporate regulations.Support the performance of the site cGMP activities.RequirementsKey Accountabilities:Comply with and execute CGMP/GDP in the performance of
day-to-day business activities.Ensure data integrity principles: Attributable, Legible,
Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and
data in day-to-day business activities.Attend and successfully complete applicable CGMP
training.Escalate any potential violation of CGMP and/or other
concerns which may affect the safety, efficacy, quality, or purity of human health products.Work collaboratively to ensure a safe and compliant
cultureParticipate in driving a high performing & inclusive
culture, stimulating personal growth & development. May be required to
perform other duties as assigned. Responsible for activities including some or all of
the following and any other tasks as required:QualityLiaise with the QC Leads to resolve quality related
queries where requiredEnsure that adequate processes and procedures are in
place and followed for all Quality activities.Where required work shift patterns in line with
manufacturing operations to ensure Quality operations (including testing,
delivery and or oversight) as required as per business needs & if needed.Provide support to the relevant support functions to
ensure manufacturing and release activities, in compliance with applicable
procedures, our Company’s Global Policies and Guidelines, regulatory
requirements and current Good Manufacturing Practices (cGMP).Develop and maintain effective cross-functional
relationships with other departments and support functions to ensure that the
process for the manufacturing, testing and release of vaccine and biologic
products are in compliance with cGMP and the associated regulatory
requirements.Identify and support compliance initiatives to improve
compliance status and overall operational efficiency for batch release at the
site.Support business critical projects related to the Quality
Department.Delivery:Responds to standard requests and communication processes
to allow the flow of appropriate information between departments.Use MPS principles and tools to identify and support
continuous improvement by active participation to ensure quality systems and
work practices are effective, efficient and ensure compliance and overall
operational efficiency for batch and material release at the site where
required.Sign approved job description. Site Business Area Support:Support in resolving routine potential quality issues.Provide quality support of controls and procedures for
the end to end material and product lifecycle where applicable.Assist team members to support the
qualification/validation, technical transfers, and commercial operations at the
facility where required. Quality Control:Supports the Laboratory and team members with day to day
activities, as applicable. Compliance Responsibilities:Ensure compliance to regulatory requirements.Assist team members with tasks relating to SOP's,
Deviations, cleaning verification/validation data and other documents as
necessary for the Quality and Manufacturing departments where required.Contribute to effective writing/revising/rolling out of
accurate operational procedures, training materials and maintenance procedures
for various Quality related systems. Other:Participate in training programs as required. Educational and Experience Requirements:Leaving Certificate or other relevant experience. Role Reporting To: Quality Control Manager/
Associate Director Quality Control#LI-AP1