QC Analytical Data Reviewer

About PSC Biotech

Who are we?

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.

Overview:

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.

Requirements

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 development of 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.
  
• Write technical reports or documentation, such as
  deviation reports, testing protocols, and trend analyses.
  
• 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.
  
• 2-3 years of analytical methodologies and
  instrumentation  experince (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.
  

Physical Demands:

• Health & Safety requirements (e.g. Manual Handling
  Training).
  

• Contract Duration: 12 Months