Quality Assurance Specialist-Evening Shift

仕事内容

This position is for the evening shift (flexible hours) and includes an evening premium.

About Capcium

We are an innovative, fully licenced value-add service platform provider for customers in the Pharmaceutical, Over-the-Counter and Health & Wellness industries. Capcium has developed a best-in-class team of softgel encapsulation professionals leveraging decades of manufacturing expertise, customer support experience and formulation customization knowledge from leading softgel manufacturers. We are dedicated to delivering the best customer experience and providing quality products while keeping our core values at the heart of everything we do.

Why work at Capcium?

We are a continuously growing company offering a unique opportunity to learn and be apart of a dynamic team. While ensuring high-quality service throughout every point in the journey, we strive for open and honest communication to create strong relationships between employees and customers. We foster a collaborative environment to ensure a drive towards shared goals and success. Our foundation is based on integrity and agility, ensuring trust amongst coworkers and quick responses to rapid changes in the internal and external environments.

Overview

The Quality Assurance Specialist will facilitate the activities of the Quality department which includes but are not limited to GMP/SOP document preparation; sustaining a robust and effective quality system that delivers reliable quality products that meet customers and regulatory agency requirements; performing internal audits, giving regulatory support, and providing back-up to the QA Director.

Main Responsibilities

• Supervise/approve the release of batches of products.
• Implementation and continuous improvement of quality procedures.
• Work closely with Production and R&D to ensure compliance is maintained.
• Investigate non-compliance situations and monitor the implementation of CAPA and complaints.
• Issuance, management, and follow-up of controlled documents, including validation reports of equipment and manufacturing process.
• Follow up with Capcium’s partners/clients to manage the various quality documents.
• Participate during audits by customers and/or regulatory agencies.
• Execute internal inspections to ensure that activities are conducted in accordance with Good Manufacturing/Production Practices (GMP/BPP) and Capcium procedures.
• Generate inspection reports and make any recommendations necessary to ensure appropriate follow-up of corrective actions, if any.
• Participation in the drafting of Standard Operating Procedures (SOP) and quality agreements.
• Ensure that timelines for specific quality projects are maintained and communicated internally and to Capcium’s partners/clients.
• Back-up for this role is the QA Director.

Qualifications

• 3-5 years of experience in a similar role in Quality Assurance in a pharmaceutical environment.
• University degree (B.Sc.) in Science (Chemistry, Biochemistry), or a related discipline.
• In-depth knowledge of Canadian Good Manufacturing Practices (GMP). Knowledge of Good Production Practices (GPP) and the regulations associated with Cannabis is an asset.
• Understanding of quality management systems, including review of manufacturing and packaging records, product release, controlled document management, change control, investigation and CAPA. Experience in pharmaceutical equipment validation is an asset.
• Excellent work organization.
• Good computer knowledge (Microsoft Office, Outlook).
• Training or experience in operational excellence programs such as Six Sigma or LEAN is an asset.
• Proven skills in problem solving.
• Ability to work effectively in a team.
• Bilingual; excellent oral and written communication skills in French and English.