QC Analytical Data Reviewer

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Galway
• State/Province Galway
• 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:

The main purpose of the QC Analytical Data Reviewermanages, organizes, coordinates and controls the Laboratory Documentationreview, training of analysts for QC Laboratory to attain the most effective andefficient deployment of human and material resources within a given budgetrespecting relevant due dates. This must be achieved through efficiency both intime and material resources, while ensuring compliance with GxP, companyprocedures, ALCOA+ requirements, most common regulations/guidelines, and best practicesas well as Pharmacopoeia standards.

Requirements

Responsibilities:

• Review routine and non-routine analyses of in-processmaterials, raw materials, environmental samples, finished goods, or stabilitysamples.
  
• Interpret test results, compare them to establishedspecifications and control limits, and make recommendations on appropriatenessof data for release.
  
• Review laboratory test data and perform appropriateanalyses.
  
• Verify documentation needed to support testingprocedures, including data capture forms, equipment logbooks, or inventoryforms.
  
• Evaluate the status of calibration of laboratoryequipment.
  
• Participate in OOS/OOT/LIR and failure investigations andrecommend CAPAs.
  
• Support development of data necessary for regulatorysubmissions.
  
• Review data of transfers of analytical methods inaccordance with applicable policies or guidelines.
  
• Identify quality problems and recommend solutions.
  
• Monitor testing procedures to ensure that all tests areperformed according to established item specifications, standard test methods,or protocols.
  
• Train other analysts to perform relevant analysisaccording to laboratory procedures and best practices.
  
• Identify and escalate equipment problems.
  
• Participate in internal assessments and audits asrequired.
  
• Evaluate analytical methods and procedures to determinehow they might be improved.
  
• Write technical reports or documentation, such asdeviation reports, testing protocols, and trend analyses.
  
• Review data from contract laboratories to ensure accuracyand regulatory compliance.
  
• Serve as a technical liaison between quality control andother departments, vendors, or contractors.
  
• Coordinate testing with contract laboratories andvendors.
  
• Write or revise standard quality control operatingprocedures.
  
• Prepare or review required method transfer documentationincluding technical transfer protocols or reports.
  
• Strong experience as Analytical Lab Analyst in QC companymanufacturing finished product working in GxP.
  
• 1-2 years of analytical methodologies andinstrumentationexperince (UPCL, HPLC,GC, potentiometric titration, particle size, IR, UV etc.).
  
• Have in-depth knowledge of Chromatography Data SoftwareEmpower.
  
• Have in-depth knowledge of transfers of analyticalmethods.
  
• Have a strong experience in data integrity management(ALCOA+), Current Good Manufacturing Practices (cGMP), FDA guidelines, andother regulatory requirements.
  
• Proactive attitude towards work and learning newtechniques.
  
• Good organizational skills.
  
• Ability to work in a team.
  

Qualifications:

• Master's degree in chemistry or similar Science degree.
  
• Excellent communication, troubleshooting and functionskills.
  
• Proficiency using MS Word and QC Labsoftware/applications.
  
• Demonstrated mathematical and statistical skills.
  
• Ability to communicate clearly and fluency in English,both orally and in writing.
  

Physical Demands:

• Health & Safety requirements (e.g. Manual HandlingTraining).