Change Control Request

2 weeks ago


Montreal, Quebec, Canada Church & Dwight Full time
A collective energy and ambition. A place where you can make a real difference.

We're a company that genuinely cares about our people, our products, our consumers and the environment.

Our unique, informal culture champions courage, determination and collaboration.

Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership.

We have a shared passion to work hard, innovate and push boundaries.

United by the belief that when we strive for growth, anything is possible.

While we might not be the largest company in our industry, we believe we can have the biggest impact because:
Together We Have the Power to Win.

POSITION SCOPE:


The main responsibilities of the position are related to the management of the change control program, the launch of imported products, and the coordination of special projects, including local and corporate initiatives.


KEY RESPONSIBILITIES:

According to current approved procedures:

  • Is responsible for the change control (CC) program: evaluates the CCs, their impacts and the identified actions. Assure actions do not conflict with existing procedures, GMPs or applicable regulations.
  • Compiles data and generates the KPIs related to the change requests.
  • Carries out the necessary followups for the completion of the related actions according to the deadlines allocated. Gathers evidence related to actions.
  • Evaluates and identifies Quality needs for all kind of projects. Takes strategic approaches to minimize project costs and delays in realization.
  • Is responsible for the launches of imported products on the Canadian market.
  • Acts as ambassador of the Church & Dwight Canada site for corporate initiatives and assumes the role of Quality Expert:
  • Shares the vision, challenges and needs of C & D Canada based on mandatory requirements;
  • Collects the comments and questions of the experts affected by the project and communicates them to the project team;
  • Accompanies the users during the project deployment, is the SME and "go to person".
SKILLS & QUALIFICATIONS

  • College degree in Sciences, B.Sc. in Sciences or Engineering is an asset
  • Minimum 3 years of experience in the pharmaceutical industry or experience deemed equivalent
  • Excellent computer skills
  • Experience in project management and/or change management
  • Excellent knowledge of Health Canada and FDA cGMPs and ISO 13485 standard
  • Strong interpersonal skills and ability to work effectively within a team;
  • Excellent writing skills
  • Bilingualism (French & English) required, oral and written
  • Knowledge of the following computer systems: Microsoft Office Suite, SAP, Agyle (Oracle), Solabs & Swisslog

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