About PSC BiotechWho 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:The Quality Specialist ensures adherence to Good
Manufacturing and Documentation Practices, client’s Quality Manual and local
procedures.The Quality Specialist spends significant time on the
shop floor in a team environment to provide quality coaching and guidance, to
enable documentation to be completed right the first time, and to ensure
compliance with cGMPs and regulatory requirements.RequirementsPrimary Responsibilities:Provide direct Quality support to production and support
areas.Provides presence on the shop floor to support compliance
and data integrity.Review and approve GMP documentation/data for accuracy
and completeness.Review and approve executed production documentation such
as electronic batch records and logbooks to ensure accuracy and compliance with
cGMPs and company procedures and ensures completion of proper remediation of
errors.QA support, review and approval of C&Q, Performance
qualification (PQ) & Process Validation documents.Support sustaining activities such as change management,
deviations, CAPAs, equipment requalification, periodic review, site maintenance
& Calibration Programs.Provides support to internal audits and regulatory
inspections.Collaborates with cross-functional team members in the
identification and implementation of continuous improvement initiatives and
action plans.Qualification and Experience: General competencies:MES experience desirableDesire to continuously learn, improve and develop.Leadership skills coupled with good oral and written
communication skills.Demonstrated interpersonal skills including flexibility,
collaboration and inclusion skills and ability to work/ upskill/coach a team
environment.Technical:Knowledge of cGMPs and of regulatory requirements as they
apply to the pharmaceutical field.Technical writing skills.Lean Six-sigma and problem solving tools. Minimum Education/Experience:Bachelor degree, in a scientific or engineering field.3 years of relevant post-degree experience in a GMP
environment: manufacturing, laboratory, quality, operations, technical, or regulatory function. #LI-AM1