Supervisor, Quality Services

2 days ago

Canada Paladin Labs Full time

**_Supervisor, Quality Services_**

**Position Summary**

The Supervisor, Quality Services is responsible for providing oversight and leading Paladin’s quality systems. This includes managing the deviations, CAPAs, complaints, product release and Mock recalls. He is involved in the change control system, management review, approval of GMP documentation and procedures. He is involved in the maintenance of compliance for all Paladin’s products and systems. He acts as the lead Quality support on assigned projects to maintain and provide continuous improvement of Paladin’s systems and products. He ensures compliance with current domestic and international GMPs and regulatory agencies. Finally, he works with cross-functional departments and suppliers for the completion of documentation related to our quality systems and batch release.

**Reports To**

Manager, Quality Services

**Specific Responsibilities**
- Contribute to the development, management, and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations, and company quality standards in support of cGxP/ ISO 13485 activities.
- Assist with all aspects of quality systems, such as Change Control, Deviations, Investigations, complaints and CAPA systems to assure compliance and timely and accurate completion of reported events.
- Supervise the QA batch release functions for cGMP commercial and distribution activities from the contract manufacturing, filling, testing and packaging facilities. Including non MRA requirements and product return process.
- Prepare and/or review controlled documents (e.g. SOP's) required for compliance.
- Supervise and coordinate Quality Services staff and/or consultants towards the timely completion of assigned duties and responsibilities.
- Attention to detail
- Excellent interpersonal skills
- Ability to communicate with customers
- Problems solving
- Well-refined people skills
- Leadership
- Ability to prioritize
- Autonomy / resourcefulness
- Work ethic and sense of responsibility

Required
- Bachelor’s degree in a relevant discipline
- 5+ years’ experience working in a Quality role in a GXP environment in the pharmaceutical or medical device industry.
- 2+ years of experience with quality management systems.
- Demonstrates a thorough understanding of fundamental GXP/ ISO 13485 terminology, concepts, regulations and industry standards.
- Technical knowledge related to investigation, root cause analysis, tech transfers and validation.
- Knowledge of records and data management systems/processes and tools.
- Knowledge of Good Documentation Practices required.
- Strong technical writing skills in addition to strong command of general grammar and usage principles.
- Strong proficiency in Word advanced Excel functions and Access.
- Bilingualism (French and English), oral and written.

**_ Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading._**:

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