QC Chemistry Analyst
2 weeks ago
- Industry Pharma/Biotech/Clinical Research
- Work Experience 1-3 years
- City Carlow
- State/Province Carlow
- Country Ireland
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.
Job Title: QC Chemistry Analyst
Role Description:
· A fantastic QC Chemistry Analyst opportunity forcandidates interested in a new challenge in a cGMP regulatory environment.
· The QC Analyst / Senior Technician QualityControl will report directly to the QC Chemistry Manager and will help us inthe expansion of this Laboratory and complete analytical method transfers andvalidation as well as commercial testing. The team works a 2-cycle shiftpattern.
· The ideal candidate will have 2- 3 years’experience in a pharmaceutical laboratory, ideally with experience in HPLC andrelevant systems and software. Core to the role is to perform testing ofsamples to support the release of our key drug products.
· The candidate will contribute to the positiveculture by providing an inclusive environment to enable team members to achievetheir best work.
Role Functions:
· Work as directed by the Quality Control Manageraccording to Company safety policies, cGMP and cGLP. Required to drivecompliance with Global policies, procedures and guidelines and regulatoryrequirements and execute Good Manufacturing Practices (cGMP) in the performanceof day-to-day activities and all applicable job functions.
· Participate in QC Tier 1 daily meetings andensure effective communication of testing progress, deviations etc
· Participate in writing/revising/ rolling outaccurate operational procedures, training materials and maintenance proceduresfor various Quality systems; ensure all work is carried out in line with same
· Operate as part of the QC team performing theallocated testing and laboratory-based duties.
· Perform various analytical techniques includingbut not limited to HPLC, (HIC, CE, IEX, HP-SEC), Capillary Electrophoresis andother compendial test methods in compliance with GMP requirements
· Peer review testing documentation and ensuringdata integrity compliance and QC Right First Time KPIs are achieved
· Participate in the laboratory aspects of OOSinvestigations
· Provide support with audit/inspectionrequirements to ensure department compliance/readiness.
· Participate in internal and external audits andinspections, taking the role of auditee for assigned areas of responsibility.
· Drive continuous improvement, perform root causeanalysis on system failures and substandard equipment performance, usingstandard tools and methods, to resolve machine and system issues e.g., FMEA,Fishbone diagrams, 5 why's etc,
· Work collaboratively to drive a safe andcompliant culture.
Experience, Knowledge & Skills:
What skills you will need:
· 2-3 years of experience in a pharmaceuticallaboratory
· A good working knowledge of HPLC systems andsoftware is desirable
· A good knowledge of cGMP, GLP, QualityManagement Systems
Initial Travel Requirements:
· Occasional travel may be required for trainingpurposes.
Qualifications & Education:
· Bachelor’s Degree or higher preferred; ideallyin Analytical Chemistry/ Biochemistry or a closely related discipline.
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