Industry Pharma/Biotech/Clinical Research
- Work Experience 1-3 years
- City Carlow
- State/Province Carlow
- Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.
'Take your Career to a new Level'
PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee Value Proposition
Employees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Overview:
- As QC Analyst you will perform and review a range oftechniques such as immunoassays, cell based potency bioassays HPLC andcompendial methods as part of routine and non-routine testing and project workto ensure processes and end products comply with corporate and regulatoryrequirements to facilitate product release. Reporting to the QC Manager youwill ensure that objectives are effectively achieved, consistent with ourrequirements to ensure compliance, safety and reliable supply to our customers.
- Our QC group ensures every single material inside ourproducts is manufactured, processed, tested, packaged, stored and distributedaligned with our incredibly high standards of quality and meets all regulatoryrequirements.Partnering across ourinternal manufacturing facilities, external contract manufacturers andsuppliers we create an interdependent global manufacturing network committed todeliver a compliant, reliable supply to customers and patients on time, everytime, across the globe.
- 4 cycle shift roles,12hours
Requirements
Responsibilities:
- Work as directed by the QC Manager / Associate Director,according to Company safety policies, cGMP and cGLP.
- Required to drive compliance with our Global policies,procedures and guidelines and regulatory requirements and execute GoodManufacturing Practices (cGMP) in the performance of day to day activities andall applicable job functions.
- Required to comply with our Global Policies, Proceduresand Guidelines, regulatory requirements and execute current Good ManufacturingPractices (cGMP) in the performance of day to day activities and all applicablejob functions.
- Develop, implement and maintain procedures that complywith appropriate regulatory requirements.
- Ensure that all Quality Systems within the department areadhered to on a daily basis.
- Operate as part of the QC team performing the allocatedtesting and laboratory-based duties.
- Ensure timely completion of all assigned data processingand reviewing.
- Ensure timely completion of Laboratory InvestigationReports and deviations through site procedures
- Participate in the timely generation of trend data,investigations, nonconformances, validation protocols, reports in support ofmethod validation/verifications and equipment qualifications.
- Participate in QC Tier 1 daily meetings and ensureeffective communication of testing progress, deviations etc.
- Peer review testing documentation and ensuring dataintegrity compliance and QC Right First Time KPIs are achieved.
- Where applicable, review, approve and trend test results.
- Participate in the laboratory aspects of OOSinvestigations.
- Provide support with audit/inspection requirements toensure 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 cause analysison system failures and substandard equipment performance, using standard toolsand methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams,5 why's etc,
- Work collaboratively to drive a safe and compliantculture
- May be required to perform other duties as assigned.
Reporting Structure: Reports to QC Manager
Qualifications & Experience - Knowledge &Skills:
Technical
- Knowledge of regulatory/ code requirements to Irish,European and International Codes, Standards and Practices.
- Knowledge of cGMP
- Laboratory Quality Systems
- Proficiency in Microsoft Office and job-related computerapplications required
- Understanding of Lean Six Sigma Methodology preferred.
- Immunoassay and cell culture experience preferable
People
- A great communicator, decisive decision-maker with aproven ability to deliver excellence
- Ability to participate in highly-effective teams.
- The desire to continuously learn, improve and develop.
- Strong leadership and interpersonal skills.
- Willingness to support the team and a strong focus ondelivering excellence.
- High personal integrity, credibility, energy andflexibility.
- Model the leadership behaviours and use the MPSprinciples to achieve success.
- Set clear performance standards; overcome obstacles; holdourselves and others accountable for achieving results.
Education:
- Bachelor's Degree or higher preferred; ideally in ascience related discipline.
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