Product Development Associate

Groupe PARIMA is a Contract Development and Manufacturing Organization (CDMO), established in 1994. For over 25 years, we have developed an expertise in the development and manufacturing of non-sterile liquids, suspensions and semi-solid drug products. https://www.groupeparima.com/fr/

Product Development Associate

The product development associate provides hands-on support to product development activities associated with product development projects and commercial products.

Responsibilities:

  • Prepare and execute lab-scale batches.
  • Perform physical testing of PDS batches.
  • Write Lab-scale batches reports and MEMO.
  • Ensure that all lab-scale batches work is performed in compliance with GMP, SOP, and regulatory standards.
  • Provide support to formulator with documentation, preparation and execution of lab-scale batches.
  • Operate, maintain and control de conformity of PDS laboratory equipment.
  • Perform swabbing for the equipment cleaning assessment and cleaning validation;
  • Write protocols and reports for the cleaning assessment and cleaning validation activities;
  • Coordinate the analytical works with chemistry and microbiological laboratories;
  • Participate in the technical assessment of new projects, working in close collaboration with internal and external collaborators;
  • Provide on-the-floor oversight of the manufacturing and packaging processes, as necessary;
  • Participate in problem solving and investigations for PDS batches and cleaning activities;
  • Document activities and data in a timely manner, ensuring pertinent information can be retrieved within a reasonable period of time;
  • Provide support to project manager with documentations, sourcing, shipment, assistance with weekly planning and occasional follow up with clients;
  • Participate in the drafting of forms, procedures, manufacturing and packaging batch records, protocols and reports necessary for the proper functioning of the PDS department;
  • Coordinate and support the inventory (raw material, API and packaging components) of product development batches;
  • Participate in the creations, execution and closure of change controls and CAPA;
  • Provide support to other product development production activities.

Skills and experience required:

  • DEC or Bachelor’s degree in Science (Chemistry, or related technical/scientific field), from a Canadian University, or an equivalent scientific diploma recognized by a Canadian University or an accredited Canadian organism.
  • Minimum of three (3) year of experience in a cGMP pharmaceutical environment.
  • Some practical experience in semi-solid dosage forms and/or process development and/or cleaning assessment,
  • Experience in formulation (Asset)
  • Dynamic and multitasking ability
  • Good working knowledge of GMP, GLP, Safety and FDA guidelines,
  • Very organized and detail oriented, with a strong focus on accurateness,
  • Good interpersonal and communication skills (both in English and French; written and spoken),
  • Strong problem solving, technical writing,
  • Proficient in Process Safety concepts and methodology,
  • Able to lead and assist in training others,
  • Able to be flexible and adapting to process schedules.

What we offer:

  • Flexible work schedule
  • Medical – dental & travel benefits
  • Group retirement plan
  • Recognition program & social activities
  • Personal days
  • Employee assistance program & online medical service
  • Hot Beverages (Hot chocolate, Coffee, Mokaccino)
  • Accessible by public transit or free parking
  • Referral program
  • Subsidized meal program

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