QC Analytical Data Reviewer

Loughrea, Co. Galway

About Chanelle Pharma:

This is an opportunity to be part of a dynamic team within the QC function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.

This is a key role in the Quality Control area reporting to the QC Manager. The main purpose of the QC Analytical Data Reviewer manages, organizes, coordinates and controls the Laboratory Documentation review, training of analysts for QC Laboratory to attain the most effective and efficient deployment of human and material resources within a given budget respecting relevant due dates. This must be achieved through efficiency both in time and material resources, while ensuring compliance with GxP, company procedures, ALCOA+ requirements, most common regulations/guidelines, and best practices as well as Pharmacopoeia standards.

KEY RESPONSIBILITIES:

  • Review routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.
  • Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
  • Review laboratory test data and perform appropriate analyses.
  • verify documentation needed to support testing procedures, including data capture forms, equipment logbooks, or inventory forms.
  • Evaluate the status of Calibration of laboratory equipment.
  • Participate in OOS/OOT/LIR and failure investigations and recommend CAPAs.
  • support relevant dept data necessary for regulatory submissions.
  • Investigate or report questionable test results.
  • Review data of transfers of analytical methods in accordance with applicable policies or guidelines.
  • Identify quality problems and recommend solutions.
  • Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
  • Train other analysts to perform relevant analysis according to laboratory procedures and best practices.
  • Identify and escalate equipment problems.
  • Participate in internal assessments and audits as required.
  • Evaluate analytical methods and procedures to determine how they might be improved.
  • Review data from contract laboratories to ensure accuracy and regulatory compliance.
  • Serve as a technical liaison between quality control and other departments, vendors, or contractors.
  • Coordinate testing with contract laboratories and vendors.
  • Write or revise standard quality control operating procedures.
  • Prepare or review required method transfer documentation including technical transfer protocols or reports.

COMPETENCIES:

  • Strong experience as Analytical Lab Analyst in QC company manufacturing finished product working in GxP.
  • Knowledge and understanding of analytical methodologies and instrumentation(UPCL, HPLC, GC, potentiometric titration, particle size, IR, UV etc.).
  • Have in-depth knowledge of Chromatography Data Software Empower
  • Have in-depth knowledge of transfers of analytical methods
  • Have a strong experience in data integrity management (ALCOA+), Current Good Manufacturing Practices (cGMP), FDA guidelines, and other regulatory requirements
  • Proactive attitude towards work and learning new techniques.
  • Good time management skills.
  • Good organizational skills.
  • Ability to work in a team.

 

QUALIFICATIONS:

  • Master’s degree in chemistry or similar Science degree.
  • Excellent communication, troubleshooting and function skills.
  • Proficiency using MS Word and QC Lab software/applications.
  • Demonstrated Mathematical and statistical skills.
  • Ability to communicate clearly and fluency in English, both orally and in writing

 

WORK ENVIRONMENT: 

  • Laboratory 

QC Data Reviewer

Reference No: J0680
Loughrea, Co. Galway