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 to support external manufacturing activities. The role involves coordinating changes, monitoring product stability, and ensuring compliance with quality standards. The ideal candidate will have a technical degree, at least 3 years of experience, and strong communication skills in both French and English.

Qualifications

• At least 3 years of experience in a production or related role within the pharmaceutical industry.
• Proficiency in both French and English.
• Excellent oral and written communication skills.

Responsibilities

• Coordinate, manage, and monitor changes in external manufacturing activities.
• Monitor stability studies and ensure compliance with good manufacturing practices.
• Prepare and request approval of purchase orders.

Skills

Attention to detail

Organizational skills

Communication skills

Interpersonal relations

Multi-tasking

Education

Technical or university degree in science or a related field

Tools

Word

Excel

PowerPoint

Outlook

Job description

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Position Summary

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

Key Responsibilities

1. Prepare and request approval of purchase orders.
2. Initiate change requests related to the manufacture of commercial products, track approvals, and close related actions.
3. Initiate deviations and corrective and preventive actions, track approvals, and close associated tasks.
4. Monitor the stability of commercial batches, including active ingredients, impurities, and finished products. Initiate in-house stability protocols and report on receipt of reports from suppliers.
5. Update and upload GxP documents to Theratechnologies' quality management system.
6. Coordinate shipments of raw materials, test samples, and finished products with relevant stakeholders.
7. Participate in invoice approval and follow-up processes.
8. Support the pharmaceutical development team in shared activities such as additional studies on commercial products.
9. Assist in drafting SOPs.

Internal Partnerships

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

Qualifications Required

• Technical or university degree in science or a related field.
• At least 3 years of experience, ideally in a production or related role within the pharmaceutical industry.
• Proficiency in Word, Excel, PowerPoint, Outlook.
• Excellent 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.
• Strong communication skills.
• Ability to multi-task effectively.
• Quick learner with curiosity.

Personal Qualities for All Staff

• Goal-oriented with the ability to meet deadlines.
• Prioritization skills.
• Creativity and problem-solving abilities.
• Ability to work independently and as part of a team.
• Team spirit and willingness to assist colleagues.
• Versatility and flexibility.

Additional Information

Seniority Level: Associate

Employment Type: Full-time

Job Function: Manufacturing, Product Management, Writing / Editing

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