Senior Executive, Quality Assurance Operations

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:

Job Summary

• Sampling activity.
• IPQA activities.
• CCR initiation, QA assessment in QMS Track wise.
• SME for Raw material sampling Packing material sampling, Liquid sampler and Tuscan operation.

Job Responsibilities

• Co-ordination & Ensuring timely execution of Sampling activity of Raw and Packing materials.
• Preparation, Review and updating of standard operating procedure.
• To ensure line clearance for dispensing, sampling and packing activity.
• Routine monitoring of all functional area to ensure adherence to the SOPs.
• Create signature and methods for raw materials by using Truscan RM analyzer.
• Approved / Rejected labels affixing for API, Excipients, Primary packing and secondary packing materials finished goods and operation supplies.
• Verification of Temperature and Relative Humidity reports generated from TESTO software.
• To perform the QMS (change control) activities as per access approvals.
• To perform necessary SAP transaction as per access approvals.
• Review and co-ordination for in-house and external calibration.
• Imparting training & co-ordination for implementation of training activities.
• In-process checks during packing.
• Sampling of Finished products.
• To ensure training completion as required.
• Review of executed batch packing records & logbooks.
• Issuance and verification of packing batch documents.
• Collection of swab sample as applicable.
• Co-ordination for Process validation / cleaning validation.
• Co-ordination for Qualification activities as applicable.
• Preparation for regulatory audits and making the compliance for the same.
• 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.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• 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.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• All other duties as assigned.

Job Requirements

• Education:

• Minimum 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.

• Preparation and review of SOP.

• Experience

• Minimum 6 years' experience in GMP Regulated Pharmaceutical industry.

• 4 to 6 years

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.