Assistant Manager, Quality Assurance

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.

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Job Summary

• To implement efficient, quality processes at ARPL in alignment with global standards that comply with heath authority requirements.
• IPQA activities, CCR initiation, Review, Approval, QA assessment, QA Responsible & final closure of CCR in QMS Track wise.
• SME for Swab/Rinse sampling, AQL, Cross contamination, MMaR'S / MPaR'S
• MMaR'S / MPaR's Review & approval in live link.

Job Responsibilities

• Ensure adherence to GMP regulatory requirements by one and all in the facility.
• Planning & Co-ordination of daily activities in Manufacturing and Packing areas.
• Co-ordination & ensuring timely execution of in-process activities for manufacturing & packaging.
• Preparation and Review of SOP & Routine monitoring of all functional area to ensure adherence to the SOPs.
• Co-ordination of change controls, SAP Notifications, Deviations and SME for QAIP related deviations. & MMaR/MPaR block/unblock in SAP system.
• Performing QA assessment for SOP'S, Protocols, Master Manufacturing Records & Master Packing records and other GMP records.
• Initiation, Coordination for implementation of CAPA.
• Quiz Review in GLMS.
• In-process checks during manufacturing & packing stage, performance & Review of AQL, collection of samples as applicable and trending of AQL.
• Sampling of SLED batches Hold time study sample, In-process samples/Finished product samples
• Collection, storage and disposal of Reserve Sample.
• Review of executed batch records & log books. Co-ordination for Process validation & cleaning validation execution.
• To perform Swab/Rinse sampling for the cleaning verification & validation programme, cleaning & verification of sampling thief's & accessories.
• Perform, Review & approval and co-ordination for in-house and external calibration.
• Review & approval of Master Manufacturing Records & Master Packing records in live link.
• Review and approval of Placebo and Submission batch documents.
• Line clearance of various in process stage such as dispensing, granulation, compression coating, sampling, primary packing and secondary packing etc.
• Preparation for internal, customers & regulatory audits and making the compliance for the same.
• Coordination for and performing gap assessment of Global Policies and Global SOPs.
• Coordination for internal, customers & regulatory audit compliance work.
• Preparation, Review & approval of Protocols and report.
• To maintain the Quality Risk Assessment for cross-contamination which includes initiating risk review activities, as required.
• Coordinate and manage Cross Contamination Control Program.
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee's progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Responsible and accountable for competently managing subordinates and to provide all required training, equipment, tools and follow procedures in accordance with applicable regulatory & other pertinent requirements.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.

Job Requirements

• Education
• Bachelor of Pharmacy/ Science or any equivalent degree.
• Knowledge, Skills and Abilities:
• Should possess good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet.
• SME for IPQA activities & Cross Contamination related activities.
• Imparting training & handling of team members (direct reports) with all compliance programs.
• Maintaining cross contamination related activities, Preparation and review of SOP.
• Live-link Track wise related to preparation and approval activities.

• Handling of Deviation, active participants for CAPA, Market complaints, LIR, Qualification related activities.\

• Experience:

• Minimum 10 Years of experience in GMP Regulated Pharmaceutical industry.

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all 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.