* Industry Pharma/Biotech/Clinical Research
* Work Experience 1-3 years
* City Dundalk
* State/Province Louth
* 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:
Reporting to the Microbiology Lead, this role willprovide online QC oversight to Drug Substance/ Drug Product manufacturingoperations. This is a crucial role within the Quality organisation withresponsibility for directly supporting the manufacturing operations team on adaily basis, ensuring compliance with cGMP and corporate and local SOPs.
Requirements
Responsibilities:
* Provide QC support to technology transfer and commercialmanufacturing operations.
* Perform QC review of SOPs, risk assessments, changecontrols and other documentation, as applicable, associated with DS/DPmanufacturing operations.
* Participate on microbiology projects, including microbialmethod validation and testing, environmental monitoring, microbial organismidentification, supporting facility qualification, cleaning validation, andprocess validation.
* Perform microbial testing and participate withatypical/OOS investigations, change controls, and CAPAs.
* Work with supervisors and other team members to reviewand monitor method performance.
* Author of technical documents including methodsprotocols, qualification / validation protocols and reports, SOPs, etc.
* Provide technical guidance, as well as evaluate /introduce new technologies in microbiology area.
* Assist Microbiology Lead to develop micro controlstrategies, quality enhancement, and operational efficiency improvement.
* Provide effective communication and play a leading rolein project management interaction with internal and external clients such asQuality Assurance, Regulatory Affairs, and Analytical Development.
* Ability to handle regulatory inspections from FDA, EMA,etc. and cGMP audits from clients, as well as internal audits.
* Ability to work in a team environment and independentlyas required.
* Perform job specific tasks in compliance with applicableRegulations, International Standards, and Policies and Standard OperatingProcedures.
* Other duties as assigned.
* Lead or participate on microbiology projects, includingmicrobial method validation and testing, environmental monitoring, microbialorganism identification, supporting facility qualification, cleaningvalidation, and process validation.
* Perform microbial testing and participate withatypical/OOS investigations, change controls, and CAPAs
* Work with supervisors and other team members to reviewand monitor method performance.
* Author of technical documents including methodsprotocols, qualification / validation protocols and reports, SOPs, etc.
* Provide technical guidance, as well as evaluate /introduce new technologies in microbiology area.
* Assist Microbiology Head to develop micro controlstrategies, quality enhancement, and operational efficiency improvement.
* Provide effective communication and play a leading rolein project management interaction with internal and external clients such asQuality Assurance, Regulatory Affairs, and Analytical Development.
* Develop and maintain high level of scientificachievements for the company; expected to be a point of contact for projectcoordination, including email and client meetings.
* Ability to handle regulatory inspections from FDA, EMA,etc. and cGMP audits from clients, as well as internal audits.
* Ability to work in a team environment and independentlyas required
* Perform job specific tasks in compliance with applicableRegulations, International Standards, and Policies and Standard Operating Procedures.
* Thorough understanding of current Good ManufacturingPractices (GMP)
Other Requirements:
* Knowledge of microbial testing and microbial control.
* Familiar with requirements of FDA and EMAregulations.
* Thorough understanding of current Good ManufacturingPractices (GMP)
* Excellent interpersonal and written and verbalcommunication skills
* Excellent planning & organisational skills
* Comfortable in a fast-paced working environment
* Able to adjust workload based upon changing priorities
* Demonstrated ability to work well in cross-functionalteams
* Results and solutions focused
* Demonstrated experience within highly regulatedenvironment.
* Ability to interpret technical documentation.
* knowledge of cGxP requirements and regulations.
* Knowledge of trouble shooting and problem-solving skills,e.g., formal root cause analysis such as Ishikawa diagrams, FMEA etc.
Education:
* BSc in Microbiology or related field. 1 – 3 years relatedindustry experience.
Shift Pattern: Day shift 7am to 7pm shift pattern. This covers weekends.
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