Deputy Manager, NOS
Deputy Manager, NOS
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Job Description
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
The Deputy Manager MS&T (Cleaning Validation) is responsible for overseeing all cleaning validation activities in compliance with GMP SOPs and global regulatory guidelines (Health Canada FDA EU). The role includes supervision training and development of personnel involved in validation protocol execution and report preparation with accountability for work scheduling project prioritization and timely resolution of roadblocks.
The position ensures strategic implementation of the Cleaning Validation program conducts technical risk assessments supports deviation investigations and drives effective CAPAs. As the department SME for cleaning validation the Deputy Manager provides technical leadership facilitates training and promotes continuous compliance and operational excellence.
Job Responsibilities
- Ensure execution of all cleaning validation activities in compliance with GMP SOPs safety standards and global regulatory requirements (FDA EU Health Canada).
- Prepare review and update Cleaning Validation Master Plan (CVMP) Validation Master Plan (VMP) and related SOPs.
- Author review and approve cleaning validation protocols reports and associated technical documentation.
- Perform risk assessments to identify worst-case products/molecules for cleaning validation and establish validation matrices.
- Prepare review and maintain quarterly/annual cleaning validation monitoring reports and related compliance records.
- Responsible for MACO calculation product and Equipment risk assessments.
- Manage cleaning validation activities through eResidue or equivalent electronic systems.
- Oversee daily operations of the Cleaning Validation group including work scheduling resourcing and ensuring timely execution of projects.
- Provide technical guidance troubleshooting and problem-solving for validation protocols reports deviations and investigations.
- Lead deviation investigations to identify root causes and ensure effective CAPA implementation.
- Review and assess changes impacting validation status using formal change control procedures.
- Act as SME for cleaning validation related activites.
- Review and optimize departmental procedures and practices to improve efficiency and compliance.
- Review and approve validation documents acting as an authorized designate in the absence of the Manager
- Support regulatory and internal inspections prepare departmental reports (monthly/annual) and present status updates to management.
- Coordinate and facilitate departmental training ensuring staff follow role-specific training and development plans.
- Mentor coach and develop staff performance through reviews oneonones and personal development plans.
- Participate in recruitment onboarding and competency building of new employees; approve vacation requests to maintain service continuity.
- Foster a highperformance culture aligned with organizational values (Collaboration Courage Perseverance Passion) and ensure adherence to all compliance and HR programs.
- Serve as the primary liaison for validation projects ensuring customer needs timelines and priorities are consistently met.
- Support budget monitoring departmental meetings continuous improvement initiatives and assume leadership responsibilities in the Managers absence.
- 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 Master Degree in Pharmacy or Science with Articles published in International Journals.
- Knowledge skills and abilities :
- Demonstrated experience in leading and motivating teams within a fast-paced environment towards common goal(s).
- Excellent oral and written communications.
- Strong interpersonal skills.
- Proven organizational time management and people management skills.
- Ability to work independently with minimal supervision.
- Strong customer service orientation.
- Experience in solid dosage formulations with an understanding of ICH Health Canada FDA EU and other applicable regulatory guidelines is an asset.
- Intermediate to advanced computer skills in MS Excel and Word. Familiarity with LabWare LIMS LiveLink/Content Server SAP and TrackWise is an asset.
- Experience
- Minimum 5 to 10 years of Experience in Cleaning Validation and exposure to Cross Contamination control of the Pharmaceutical product in GMP Regulated 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.
Required Experience:
Manager
Employment Type
Full Time
