Spécialiste de la fabrication externe | Specialist, External Manufacturing

Theratechnologies Inc.; Montreal; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Manufacturing Specialist responsible for supporting external manufacturing activities. The role involves coordinating changes, managing deviations, and ensuring compliance with quality standards. Ideal candidates will have a technical degree and relevant experience in production.

Qualifications

• 3 years' experience in production-related position in pharmaceutical industry.

Responsibilities

• Prepare and request approval of purchase orders.
• Initiate change requests and track approvals.
• Monitor stability of commercial batches.

Skills

Attention to detail

Organizational skills

Oral communication

Written communication

Education

Technical or University degree in science

Tools

Word

Excel

Power Point

Outlook

Job description

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Partenariats internes

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Position Summary

The candidate is responsible for supporting Theratechnologies' external manufacturing activities by coordinating, managing and monitoring new changes, initiating and closing deviations and preventive and corrective actions, and monitoring commercial product stability studies to ensure compliance with good manufacturing practices and the quality of products brought to market.

Key Responsibilities

• Prepare and request approval of purchase orders.
• Initiate change requests related to the manufacture of commercial products, track approvals and close actions related to these requests.
• Initiate deviations and corrective and preventive actions related to the manufacture of commercial products, track approvals and close associated tasks.
• Responsible for monitoring the stability of commercial batches (active ingredient, impurities, finished products). Initiate in-house stability protocols and reports on receipt of reports from suppliers.
• Update and upload GxP documents to Theratechnologies' quality management system.
• Coordinate shipments of raw materials, test samples and finished products with all relevant stakeholders.
• Participate in the invoice approval and follow-up process.
• Support the pharmaceutical development team in shared activities such as additional studies on commercial products.
• Participate in the drafting of SOPs.

Internal Partnerships

• Pharmaceutical Development, Quality Assurance, Regulatory Affairs, Supply Chain, Finance.

Qualifications Required

• Technical or University degree in science or related field.
• 3 years' experience, ideally in a production or production-related position in the pharmaceutical industry.
• Knowledge of Word, Excel, Power Point, Outlook.
• Oral and written communication skills in French and English.

Personal qualities specific to the position

• Attention to detail and organizational skills.
• Ability to establish and maintain excellent interpersonal relations.
• Excellent oral and written communication skills.
• Ability to multi-task with ease.
• Ability to learn quickly and curiosity.

Personal Qualities for all Staff

• Ability to set goals and meet deadlines
• Ability to prioritize
• Ability to generate ideas and find solutions
• Ability to work independently and in a team environment
• Team spirit and willingness to assist team members
• Versatility and flexibility

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing, Product Management, and Writing/Editing

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