Current jobs related to Coordinator, QAip - Richmond Hill, Ontario - Apotex

About Apotex Inc.

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
Job 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 and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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