Job description: Job Title: QA Associate Location: On-Site Job Type: Full-time ( Contract) Industry: Generic Pharmaceutical Experience Level: Intermediate (2-4 years) Company Profile: Auro Pharma Inc. is a Canadian subsidiary of Aurobindo Pharma, a vertically integrated global pharmaceutical organization involved in the manufacture of finished dosage formulations, Drug Intermediates, Active Pharmaceutical Ingredients (APIs), and Research & Development activities, with operations across 165 countries and a workforce of over 33,000 employees worldwide. Auro Pharma Inc. is one of the fastest-growing generic pharmaceutical companies in Canada, offering a broad portfolio of prescription products, including oral and injectable dosage forms, across key therapeutic areas such as Anti-Infectives, Anti-Retrovirals, Cardiovascular, Central Nervous System, and Pain Management. Auro Pharma Inc. markets and distributes pharmaceutical products throughout Canada through major pharmaceutical distribution channels while maintaining compliance with Health Canada’s Food and Drugs Act, Food and Drug Regulations, and current Good Manufacturing Practices (GMP) requirements. Summary of Position The Quality Assurance Associate will support the Quality Assurance team in ensuring compliance with Health Canada GMP requirements and applicable international regulatory standards. The position will assist in the implementation and maintenance of the Pharmaceutical Quality System, ensuring product quality, patient safety, and regulatory compliance throughout the product lifecycle. The QA Associate will work closely with internal departments, contract manufacturing organizations (CMOs), testing laboratories, warehouses, and global quality teams to support activities related to batch release, quality documentation, deviations, CAPA, change control, complaints, recalls, audits, and regulatory inspections. The successful candidate will demonstrate strong knowledge of GMP principles, quality systems, and Health Canada requirements applicable to pharmaceutical drug products, including sterile and non-sterile dosage forms. Responsibilities Batch Release & Product Disposition Review and assess batch release documentation, including Certificates of Analysis (CoAs), Certificates of Compliance (CoCs), executed batch records, packaging records, laboratory results, and associated quality documentation. Coordinate with manufacturing sites, contract laboratories, warehouse operations, and global QA teams to support timely batch disposition and release activities. Ensure batch release activities comply with Health Canada requirements for imported drug products and applicable GMP guidelines. Prepare and review product release documentation and quality records as per approved procedures. Quality System: Support implementation and maintenance of the Quality Management System (QMS) in compliance with Health Canada GMP requirements. Maintain GMP documentation in accordance with Good Documentation Practices (GDP). Compliance & Inspection Readiness Ensure compliance with Health Canada regulations, including: Food and Drugs Act and Regulations Division 2 GMP requirements Applicable Health Canada guidance documents (GUI series) PIC/S GMP principles Support preparation and execution of Health Canada inspections, customer audits, and internal audits. Assist in inspection readiness activities, including document retrieval and quality system assessments. Investigations & Continuous Improvement Support review of Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and laboratory investigations. Participate in root cause analysis and effectiveness checks for CAPA implementation. Identify opportunities for continuous improvement of quality processes. Documentation & Training Review and assist in preparation, revision, and implementation of Standard Operating Procedures (SOPs). Ensure completion and maintenance of GMP training records. Support controlled document management activities. Recall & Quality Events Support QA management during product recalls, market actions, and critical quality events. Assist with investigation, communication, documentation, and regulatory reporting activities as required. General Quality Responsibilities Maintain a high level of GMP compliance and quality culture. Support cross-functional teams during quality-related activities. Work extended hours, including weekends, when required to support critical quality events, regulatory commitments, or business needs. Perform other duties as assigned. Qualifications & Experience Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Biology, Microbiology, Chemistry, or related scientific discipline. Minimum 2 years of Quality Assurance experience within the pharmaceutical industry, preferably involving sterile and/or non-sterile drug products. Experience working with Health Canada GMP requirements and pharmaceutical quality systems. Knowledge and practical experience supporting pharmaceutical importation quality activities, including batch review, certification, release, and disposition processes for imported drug products; GMP documentation practices and Good Documentation Practices (GDP) requirements; management and investigation of deviations, quality events, and non-conformances; CAPA management, including root cause analysis and effectiveness assessments; change control systems and quality/regulatory impact assessments; review and support of OOS/OOT investigations; regulatory inspection readiness activities, including Health Canada inspections, customer audits, and internal audits; and quality oversight activities involving foreign manufacturing sites, contract testing laboratories, and supply chain partners. Strong analytical, problem-solving, and organizational skills. Excellent written and verbal communication skills. Ability to manage multiple priorities in a fast-paced pharmaceutical environment. Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and ability to learn electronic quality management systems (eQMS). Experience with ERP/LIMS/eQMS systems is an asset. Bilingual French/English is considered an asset. Working Conditions This is an on-site position requiring regular collaboration with Quality Assurance, Warehouse, Regulatory Affairs, Supply Chain, manufacturing partners, contract laboratories, and other internal and external stakeholders. The role requires strong attention to detail, effective GMP documentation practices, and a commitment to maintaining the highest standards of product quality, regulatory compliance, and patient safety. The position may require flexibility to support critical quality activities, regulatory commitments, investigations, audits, and product release timelines when necessary. Job Type Full-time Contract Benefits On-site parking Schedule Monday to Friday

Auro Pharma Inc. is an equal-opportunity employer and values diversity in our workplace. Reasonable accommodation is available upon request throughout our recruitment and selection process.