Assistant Manager

Role Overview: As part of Apotex Inc., you will be responsible for the effective review and approval of Change controls, Laboratory investigation reports, Deviations, Lab events, and Corrective action and preventive action (CAPAs). Your role will involve reviewing and approving various reports and procedures to ensure compliance with regulatory standards and quality control measures. Key Responsibilities: - Review and approval of lab investigation reports, Deviations, Questionable results, Out of specification (OOS) and Out of trend (OOT) investigations. - Preparation and review of Standard operating procedures. - Review and approval of lab events and Temporary changes. - Coordinating with cross-functional teams for the closure of investigations in a timely manner. - Responsible for review and approval in various stages of change controls such as QA Acceptance, Change control assessment, QA summary, M-Doc approvals, action item verification & Final closure. - Coordinating with the regulatory department for regulatory submissions/Post-approval changes. - Review and approval of CAPA and LIR trend reports. - Approval of Specification/Certificate of analysis and method of analysis. - Support regulatory and customer audits. - Identify system improvement opportunities for process efficiency. - Work independently and as part of intra/interdepartmental teams to ensure timely completion of work to meet compliance. - Respond immediately to queries from cross-functional teams. - Participate in performance conversations with employees, including monthly one-on-ones, to monitor progress, offer support, and communicate performance expectations. - Build trust-based relationships with employees and business partners through open, honest communication. - Foster a culture of trust, employee development, and growth aligned with the company's values. - Attract and hire talent to support company growth, onboard new employees, and ensure adherence to compliance programs and company policies. Qualifications Required: - Education: Minimum MSc/B. Pharm degree or equivalent. - Experience: Minimum 10 years of experience in GMP regulated pharmaceutical industry. - Knowledge, Skills, and Abilities: - Good technical knowledge with problem-solving and logical thinking capabilities. - Competent verbal and written communication skills. - Strong management, leadership, and communication skills. About Apotex Inc.: Apotex is a Canadian-based global health company dedicated to improving access to affordable medicines and health products worldwide. With a broad portfolio of pharmaceuticals and consumer health products, Apotex is committed to fostering a welcoming and accessible work environment where everyone feels valued, respected, and supported to succeed. Accommodations for applicants with disabilities are available as part of the recruitment process to ensure equal opportunities for all candidates.,