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In-Process Quality Coordinator
In-Process Quality CoordinatorApotex Inc. • Richmond Hill, York Region, CA
In-Process Quality Coordinator

In-Process Quality Coordinator

Apotex Inc. • Richmond Hill, York Region, CA
Il y a 9 jours
Type de contrat
  • Temps plein
Description de poste

Join to apply for the In-Process Quality Coordinator role at Apotex Inc.

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit : www.apotex.com.

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).
  • Provide ongoing quality oversight and direct support of quality systems in the areas of in-process bulk testing and batch record review.
  • Collect and deliver cleaning validation samples, and complete the required documentation for validation activity.

Job Responsibilities

  • Work 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.
  • Provide support to investigations and implementation of CAPAs within the QAIP department.
  • Work as a team member along with Coordinators / Production to investigate and address non-conformances and prevent reoccurrence.
  • Generate investigations 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 appropriately and deviations are fully explained and supported by necessary documentation.
  • Review and approve applicable sterile and non-sterile Production documents according to established priorities and standards.
  • Record the receipt, review, and release of all batches in QA Supply Database to ensure compliance with business requirements.
  • Oversee the control and archiving of production / packaging logbooks and provide feedback where applicable.
  • Provide QA oversight of all activities on the Production lines, ensuring established documents and procedures are followed by performing on-line batch document review to ensure full compliance with Apotex procedures and GMP requirements.
  • Perform sampling, inspection, and review of physical testing on in-process / investigational samples and report results in SAP and LIMS where applicable.
  • Support the Coordinator, QA In-Process QS7 in regularly scheduled inspection / audits of the production / packaging area.
  • Support customer complaint investigations as required.
  • Support the cleaning validation program by coordinating and performing sampling of equipment for cleaning validation, verification, and monitoring activities per Apotex procedures and GMP requirements.
  • Perform reserve sample inspections and waste disposal as required.
  • Log samples into SAP and forward them to required testing laboratories of QC or Microbiology.
  • Ensure training records are accurate and completed according to cGMP.
  • Provide training to new Coordinators.
  • Perform all other relevant duties as assigned.

    • Job Requirements

    Education

  • Community College Diploma / University degree (or equivalent) in a related discipline.

    • Knowledge, Skills and Abilities

  • 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, changing environment.
  • Demonstrated ability to work individually and in a team environment.
  • Familiarity with Word, Excel, Access is 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 a welcoming and accessible work environment, where everyone feels valued, respected, and supported to succeed.

    We offer 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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