Pharmaceutical Quality Specialist

2 months ago

Toronto, Canada Isologic Innovative Radiopharmaceuticals Full time

**ISOLOGIC Innovative Radiopharmaceuticals** offers you an exceptional opportunity to join our dynamic team as a Pharmaceutical Quality Specialist If you’re passionate about upholding high-quality standards, nuclear medicine, and want to make a significant contribution to patient care while working in a stimulating and dynamic environment, then this opportunity is for you.

**ISOLOGIC **is a national company dedicated to nuclear medicine and radiopharmaceutical production. Our mission is to assist physicians by providing the most relevant radiopharmaceutical products for PET and SPECT in a safe and reliable manner, thereby contributing to saving lives.

**Your role with us**:As a Pharmaceutical Quality Specialist, your role involves overseeing and upholding the quality systems at our Toronto facility. This includes ensuring compliance with internal policies and procedures, delivering and monitoring training for all staff to support the program, and ensuring thorough and accurate documentation.

**Key Duties & Responsibilities**
- Reviews production, quality control and material specification documentation and primarily responsible for material and product release.
- Documents and investigates ongoing OOS and deviation. Make sure they are investigated and resolved in a timely manner.
- Performs basic troubleshooting, suitability testing and maintenance on QC equipment (HPLC, GC and others).
- Ensures site adherence to Quality Systems.
- Trains Operations, QC, distribution employees and contractors on quality control, quality assurance, manufacturing and on other topics from its fields of knowledge.
- Conducts QA activities including revision and / or creation of SOPs, site aseptic program, sterility assurance, change control, environmental monitoring, vendor management, stability studies, inspection and release of materials and the issuance of protocols.
- Works with the Operations team to analyze and trend product performance through completion of trend analysis and Annual Product Quality Reports in timely manner.
- Works closely with Facility Manager to ensure employees are working in compliance with internal policies and procedures, external client expectations, and GMPs.
- Monitors and supports the implementation of continuous improvements and process changes to ensure these are implemented in compliance with GMP and Company policies.
- Hosts regulatory inspections: (1) Develops, in conjunction with operations, documented corrective action plan for noted deficiencies. (2) Monitors completion of corrective action for noted deficiencies in timely manner

**Knowledge & Competencies Required**
- Bachelor’s degree required in a scientific discipline from a Canadian university or equivalent.
- Minimum 3-years work experience in a GMP pharmaceutical environment within Quality Assurance / Control.
- Demonstrate detailed knowledge of GMP’s, GLP’s, and aseptic process.
- Strong report writing ability.
- Strong interpersonal skills with an emphasis on effective communications and ability to work with diverse personalities and skill levels.

Join the **ISOLOGIC** team and enjoy a pleasant, productive, and stimulating working environment, where your ideas and know-how will be encouraged. Take part in challenges that match your talent and contribute to our mission of saving lives through innovative nuclear medicine solutions. In a dynamic and adaptable environment, focused on continuous improvement, your new ideas and expertise will be fully appreciated.

**OUR** **VALUES**:ETHICS AND INTEGRITY** - **CUSTOMER FOCUS** - **COLLABORATION** - **INNOVATION** - **PASSION** - **EXCELLENCE**

**Benefits**:

- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- RRSP match
- Vision care

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday

Work Location: In person

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