Scientific writer

Neopharm Labs Inc - Blainville, QC (30+ days ago)

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WHO ARE WE?

Neopharm Labs is a full-service analytical laboratory working closely with several clients in the pharmaceutical and cosmetic fields. Our team is composed of 200 dedicated professionals!

WHY WORK AT NEOPHARM?

For all the following reasons and many more!

  • Work with a united and dynamic team;
  • Avoid traffic;
  • Benefit from a flexible work schedule;
  • Benefit from a group insurance program;
  • Benefit from a pension plan;
  • Participate in several social activities.
HERE IS THE TYPE OF COLLEAGUE WE ARE LOOKING FOR:
You have:
  • A bachelor's degree in chemistry, biochemistry or a DEC in chemistry with relevant experience in the pharmaceutical field;
  • 3 years of experience in analytical validation or technical documentation;
  • Experience working in a regulatory environment (GMP);
  • A good knowledge of ICH Q2A and Q2B standards;
  • A good knowledge of the main equipment used in the laboratory (HPLC-UV, GC-FID);
  • Knowledge of pharmacopoeias (USP, Ph. Eur);
  • Excellent written English;
  • Knowledge of certain statistical tools;
  • A good knowledge of the Microsoft suite tools;
  • Good analytical judgment (critical thinking).
You are:
  • Organized;
  • Mobilized;
  • honest;
  • Available;
  • Flexible.
Job Description:
The scientific writer is responsible for writing protocols, methods and reports describing the validation of analytical methods according to Neopharm Labs Inc. and our customer’s criteria. In order to meet our customers’ needs, all documents from the validation team are written in English and transferred to the various regulatory authorities and the laboratory. These documents must also comply with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOP).

Specific responsibilities:
  • Write, review and / or verify methods, protocols, reports and other documents related to validation, transfer or any other study carried out in the validation team in accordance with Neopharm procedures and customer requests.
  • Check and / or correct the raw data to ensure that it contains everything required by the appropriate validation protocol and meets the BPF criteria.
  • Communicate with clients for revisions and / or corrections of documents.
  • Communicate with laboratory staff to obtain and / or clarify any information necessary for the drafting of validation documents.
  • Inform your supervisor immediately if a method does not meet a validation criterion.
  • Ensure the implementation of validated methods in the current database for their use in the laboratory.
  • Perform method reviews as well as quality documentation required to support these reviews (eg Change Control) when requested by a customer or Neopharm operations.
  • Manage validation training binders and archive validation files.
  • Assume other related tasks which will, following a mutual agreement, be assigned by the immediate supervisor.
It would be a pleasure to have you on our team!