Coordinator, QAip

**About Apotex Inc.**

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

**Job Summary**:

- Responsible for ensuring that quality products (including compounding, and sterile and non-sterile filling and packaging) are manufactured and packaged according to Good Manufacturing Practices (GMP) and established Standard Operating Procedures (SOP)
- Responsible to provide on-going quality oversight and direct support of quality systems in the areas of in-process bulk testing and batch record review
- Responsible for the collection and delivery of cleaning validation samples, and the completion of the required documentation for validation activity

**Responsibilities**:

- Works in a safe manner collaborating as a team member to achieve all outcomes
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies
- Have required working knowledge to operate SAP, LIMS, and Trackwise systems
- **Quality Systems**:

- Provide support to investigations and implementation of CAPAs within the QAIP department
- Work as a team member along with Coordinators / Production to achieve all tasks / activities required to adequately investigate and address the non-conformances and prevent reoccurrence
- Generate investigations as an observing department when deviations from established procedures or acceptance criteria are observed
- Report any deviations found during review of sterile and non-sterile in process batch documents to the Coordinator, QA In-Process QS7 / Supervisor / Production personnel. Ensure all document corrections are made in the appropriate manner and ensure that all deviations are fully explained and supported by the necessary documentation
- **Document Review**:

- Review and approve applicable sterile and non-sterile Production documents according to established priorities and standards
- Record the receipt, the review and the release of all batches in QA Supply Database to ensure that batches are appropriately processed through the supply chain in order to meet compliance and business requirements
- Oversee the control and archiving of production / packaging logbooks and also review for completeness and provide feedback where applicable
- **Quality Support**:

- Provide QA oversight of all activities on the Production lines ensuring that established document and procedural requirements are followed by performing on-line batch document review to ensure full compliance with established Apotex procedures and GMP requirements
- Perform sampling, inspection and review of physical testing on in-process / investigational samples and reporting of results in SAP and LIMS where applicable for completeness
- Provide support to the Coordinator, QA In-Process QS7 in the regularly scheduled inspection / audits of the production / packaging area
- Support customer complaint investigations as required
- **Validation (Cleaning Validation)**:

- Support the cleaning validation program by coordinating and performing sampling of equipment for cleaning validation, verification and monitoring activities as per Apotex procedures and GMP requirements
- **QAIP Support Activities**:

- Performs reserve sample inspections and waste disposal as required
- Log in samples into SAP and forward them to the required testing laboratories of QC or Microbiology
- Ensure that individual training records are accurate and completed according to cGMP
- Provides training to new Coordinators
- All other relevant duties as assigned.

**Job Requirements**:

- Education
- Community College Diploma / University degree (or equivalent) in a related discipline
- Knowledge, Skills and Abilities
- Must be familiar and knowledgeable with GMP and quality requirements
- Strong English verbal and written communication skills
- Excellent organizational skills and ability to manage time effectively
- Ability to follow instructions according to written procedures
- Ability to manage multiple priorities in a fast-paced and changing environment
- Demonstrated ability to work individually and in a team environment
- Familiarity with Word, Excel, Access would be an asset
- Flexibility to work shifts
- Experience
- Minimum 2 years of experience in a pharmaceutical quality and / or production environment

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected