QC NPI Analyst

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:

• This is an opportunity to be part of a dynamic team
  within the Quality Control New Product Introduction function. We are looking
  for individuals who will support and drive client’s Pharma 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.
  
• In this role you will report into the QC Manager.
  

Requirements

Responsibilities:

• Displays the capability to learn and understand methods
  showing competency in the following technical areas: HPLC, GC, IR, UV,
  dissolution & Physical testing.
  
• To carry out analytical testing on Raw Materials, API and
  Excipients using the correct Analytical procedures (e.g. API suppliers
  Analytical methods or Pharmacopeia Monograph methods as required) while
  complying with GMP, SOP’s Health, Safety and Environmental and Regulatory
  requirements with minimum Human error as per relevant timelines.
  
• Plan, prioritise and execute analytical activities in
  alignment with Team Leader, Purchasing, R&D and Product Launch in order to
  meet R&D and Launch project timelines and agreed New Product Introduction
  priorities.
  
• Adapt testing priorities in response to evolving R&D,
  Product Launch and Purchasing requirements, in agreement with the QC Manager,
  to support successful product development and launch.
  
• Preparation of ECP’s and support Vendor Approval.
  
• Performing Analytical Method Transfers related to any Raw
  Materials & Packing materials (as applicable) with Protocol / Report
  preparation.
  
• Performing Analytical Method Validation / Verifications
  related to any Raw Materials & Packing materials (as applicable) with
  Protocol / Report preparation.
  
• Characterization of APIs and Reference Products for the
  proposed Medical/Veterinary Raw Materials Products (as required).
  
• Approval of Raw Materials and the issue of associated
  documents and labels (as applicable).
  
• Responsible for sending & following up samples where
  External testing is required and receiving, filing the External testing results
  followed by circulating to relevant stakeholders(as applicable).
  
• Responses to queries from Third parties / Regulatory
  Authorities as per agreed timelines.
  
• Writing Technical Reports.
  
• Ensuring timely availability and liaising with external
  suppliers/vendors (if required) for Reagents/Chemicals/Analytical test Methods
  & Columns required in routine analysis to avoid delays in testing.
  
• Ensure the log books/experiment registers / Laboratory
  notebooks are completed contemporaneously.
  
• Reviewing Analytical raw data associated Raw Material
  testing, Analytical Method Validation/ Verification etc. (if required).
  
• Generation of data to support existing ECPs changes in
  case of DMF/Supplier technical data update(as required).
  
• Calibration and maintenance of laboratory equipment as
  per calibration procedures (as required).
  
• Making the NPI process more efficient (lean management)
  where appropriate suggestions shall be made for Continuous improvement.
  
• Communicating with other departments (R&D/QC/Product
  Launch/Quality Assurance/Regulatory Affairs/Purchasing) and following up with
  them in relation to any queries in timely manner.
  
• Filing, reporting & organisation of raw data
  generated during analysis.
  
• To bring to the notice of the Supervisor QC NPI if any
  discrepancies, deviations or non-conformances in testing or with work practice
  while complying to cGMP & Data Integrity principles.
  
• Perform detailed root cause investigations into OOS /OOT/
  Laboratory Incidents that occurs in any analysis performed.
  
• Represent company in times of Internal/External audits
  (either from Customer or regulatory authorities).
  
• Maintain the QC Laboratory up to GLP standards and adhere
  to any agreed internal laboratory rota tasks.
  
• To maintain good housekeeping and hygiene within the
  laboratory and adherence to laboratory safety measures at all times.
  
• Any other duties as assigned by the Team Leader or
  Manager.
  
• If decided appropriate it may be decided to amend/update
  any of the above responsibilities.
  

Competencies:

• Working experience in a GMP Laboratory or R&D
  (Formulation) or Raw material testing is a distinct advantage.
  
• Proficiency with Microsoft Office suite.
  
• Excellent communication and interpersonal skills with
  good collaborative skills.
  
• An ability to work independently and as a member of a
  team in a dynamic, fast-paced environment.
  
• Excellent written and communication skills.
  
• Ability to build relationships and collaborate with
  others.
  
• Maintains the highest standards of ethical behaviour.
  Escalates issues appropriately.
  
• Flexible and shows willingness to learn to develop
  technical skills.
  
• Takes a methodical, systematic, and structured approach
  to organising work.
  
• Positive and proactive person who is energized by having
  great responsibility.
  

Qualifications:

• 3rd level qualification – bachelor’s degree in a
  chemistry-based discipline.
  
• Experience in Analytical Method      Transfer, Technical Transfer,Analytical  Method Validation/Verification & Raw Material
  Testing
  
• 3+ years’ experience in a R&D/QC Analyst role.
  
• Experience working within a pharmaceutical cGLP/cGMP
  Environment; with knowledge of EU GMP and US FDA Guidelines.
  

• To take reasonable care for their own safety, health and
  welfare at work and that of any other person that may be effected by their acts
  or omissions while at work.
  
• To cooperate with client or any of its representatives
  that will enable the company to comply with the relevant health and safety
  statutory provisions.
  
• Adheres to safety regulations by ensuring correct usage
  of PPE in the lab area.
  
• Reports to the Supervisor or health and safety
  representative without unreasonable delay any defects in plant, equipment,
  place of work, system of work which might endanger safety, health or welfare of
  themselves or any employee, contractor or visitor to the company.
  
• Keeps work area safe, clean and tidy.
  
• Not to intentionally or reckless interfere with or misuse
  any appliance, protective clothing, convenience, equipment or other means or thing provided.
  

Work Environment: (eg. Office, Production)

• Duties for this position will predominantly be Laboratory
  based.