Spécialiste, spécifications (Temporaire 12 mois)

Do you want to put your expertise to work for the greatest number of people? Do you want to make a difference by harnessing your talent in the service of human health?

A healthier world starts with you! You’re the vital link between our drugs and our patients. Choosing Pharmascience is also about choosing you, because human health including your own is at the heart of our mission, and your personal and professional growth is of the utmost importance to us.

Being able to grow is what working with a leading Canadian generic pharmaceuticals company is all about

The specification specialist is responsible to establish and to maintain analytical specification for products, raw materials and packaging components.

The incumbent must therefore : Know Health Canada regulations, ICH guidelines and various pharmacopoeias; Ensure the creation and revision of specifications;

Closely follow up on all its activities and communicate information in order to respect the committed timelines.

Responsibilities :

Specification Management

• Create and revise specifications
• Issues the official specification for approval by the signatories;
• Completes and submits Change Control
• Adjust specifications according to analytical methods, PMS product and regulations
• Exchange of information with Regulatory Affairs regarding limits and tests to be included (regulatory point of view);
• Writes supporting documents detailing the choice of tests and their limitations included in the specification.
• Evaluates the specifications of business partners
• Compares specifications issued by third parties to government and Pharmascience requirements;

Applies the regulations

• Masters ICH and Health Canada recommendations at the analytical level (via guidelines, clarifax and the regulatory affairs department) and stays up to date with regulatory requirements;
• Checks the evolution of Pharmacopoeias (USP, EP, BP, Pharmacopeial Forum and Pharmeuropa) and assesses the impacts of changes on projects.

Related Tasks

• Provides recommendations to improve processes;
• Participates in major corporate projects;
• Participates in the drafting and revision of SOPs;
• Participates in project meetings.
• Answer questions from customers, partners and colleagues about specifications.
• Write and review reports for elemental impurities
• Write and review reports for residual solvents

Skills, Knowledge and Abilities :

• Excellent interpersonal relationships;
• Exemplary character, committed and motivated by the mission of Pharmascience;
• Excellent problem-solving ability;
• Practical sense and strong results orientation;
• Collaboration and openness to decisions;
• Flexibility, organization and reprioritization in the face of tight deadlines, new needs or unexpected obstacles;
• Good management and planning skills;
• Excellent communication skills, bilingualism in French and English
• Sense of responsibility;
• Sense of innovation;
• Stress resistance;
• Knowledge of Microsoft tools;
• Knowledge of the guidelines of various authorities (FDA, ICH, TPD);
• Knowledge of pharmacopoeias (USP, BP, EP).
18 days ago