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:
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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.
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In this role you will report into the QC Manager.
Responsibilities:
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Displays the capability to learn and understand methods showing competency in the following technical areas: HPLC, GC, IR, UV, dissolution & Physical testing.
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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.
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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.
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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.
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Preparation of ECP’s and support Vendor Approval.
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Performing Analytical Method Transfers related to any Raw Materials & Packing materials (as applicable) with Protocol / Report preparation.
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Performing Analytical Method Validation / Verifications related to any Raw Materials & Packing materials (as applicable) with Protocol / Report preparation.
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Characterization of APIs and Reference Products for the proposed Medical/Veterinary Raw Materials Products (as required).
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Approval of Raw Materials and the issue of associated documents and labels (as applicable).
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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).
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Responses to queries from Third parties / Regulatory Authorities as per agreed timelines.
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Writing Technical Reports.
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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.
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Ensure the log books/experiment registers / Laboratory notebooks are completed contemporaneously.
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Reviewing Analytical raw data associated Raw Material testing, Analytical Method Validation/ Verification etc. (if required).
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Generation of data to support existing ECPs changes in case of DMF/Supplier technical data update(as required).
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Calibration and maintenance of laboratory equipment as per calibration procedures (as required).
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Making the NPI process more efficient (lean management) where appropriate suggestions shall be made for Continuous improvement.
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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.
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Filing, reporting & organisation of raw data generated during analysis.
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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.
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Perform detailed root cause investigations into OOS /OOT/ Laboratory Incidents that occurs in any analysis performed.
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Represent company in times of Internal/External audits (either from Customer or regulatory authorities).
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Maintain the QC Laboratory up to GLP standards and adhere to any agreed internal laboratory rota tasks.
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To maintain good housekeeping and hygiene within the laboratory and adherence to laboratory safety measures at all times.
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Any other duties as assigned by the Team Leader or Manager.
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If decided appropriate it may be decided to amend/update any of the above responsibilities.
Competencies:
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Working experience in a GMP Laboratory or R&D (Formulation) or Raw material testing is a distinct advantage.
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Proficiency with Microsoft Office suite.
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Excellent communication and interpersonal skills with good collaborative skills.
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An ability to work independently and as a member of a team in a dynamic, fast-paced environment.
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Excellent written and communication skills.
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Ability to build relationships and collaborate with others.
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Maintains the highest standards of ethical behaviour. Escalates issues appropriately.
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Flexible and shows willingness to learn to develop technical skills.
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Takes a methodical, systematic, and structured approach to organising work.
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Positive and proactive person who is energized by having great responsibility.
Qualifications:
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3rd level qualification – bachelor’s degree in a chemistry-based discipline.
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Experience in Analytical Method Transfer, Technical Transfer,Analytical Method Validation/Verification & Raw Material Testing
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3+ years’ experience in a R&D/QC Analyst role.
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Experience working within a pharmaceutical cGLP/cGMP Environment; with knowledge of EU GMP and US FDA Guidelines.
Physical Demands:
Health & Safety requirements (eg. Manual Handling Training)
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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.
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To cooperate with client or any of its representatives that will enable the company to comply with the relevant health and safety statutory provisions.
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Adheres to safety regulations by ensuring correct usage of PPE in the lab area.
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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.
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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.
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Work Environment: (eg. Office, Production)
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Duties for this position will predominantly be Laboratory based.
