Coordinator, Validation Support

6 months ago

North York, Canada Apotex Full time

About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

Job Summary

Responsible for coordination and execution of validation activities within the QA Validation & Engineering Department. This role has individual responsibility for coordination and execution of validation related project deliverables (e.g. protocol creation and execution, data analysis, reporting) with respect to equipment, process, and sterile/aseptic Performance Qualification (e.g. airflow assessments, VHP, moist heat validation, process validation).

Acts as a resource with process validation and production systems knowledge pertaining to filling/packaging and sterilization processes installed at the site. Provides support to investigations and development of study protocols as required.

Job Responsibilities
Writes, reviews, and, where applicable, executes all validation risk assessments, validation protocols, and validation reports related to process and sterilization validation. In developing these protocols, the parameters of the study and the sampling and testing criteria are designed for worldwide regulatory compliance (FDA, HPFBI, EC and ICH standards).
Coordinates execution, analyses data, and summarizes results for Sterilization Validation protocols.
Provides training on validation topics as required to Validation Team Members, and potentially to outside departments and organizations.
Performs technical review of commissioning/validation protocols prepared by Engineering, and Equipment & Facilities Qualification team members. Performs peer review of validation documentation for errors/omissions, comprehension and compliance with cGMP and SOPs.
Reviews, initiates and recommends changes to SODs, and Production master documents. Reviews the impact of proposed changes to Production master documents and SODs via CCR and investigations with respect to the validation status of products and/or processes
Communicates and escalates validation deviations in a timely manner. Provides troubleshooting assistance and suggest remedial and corrective actions in the case of unacceptable validation results. Leads investigations by assembling and coordinating cross-functional teams to determine root cause and corrective actions for unacceptable validation results.
Provides technical assistance related to validation to customers and various departments and divisions within Apotex. May sit on necessary project teams as required.
Operates and maintains validation equipment/instruments and consumables.
Assists in calibration and calibrates validation equipment/instruments as required.
Communicate with equipment/consumables suppliers to obtain required technical information.
Ensures that procedures, work instructions and master documents describe critical parameters or ranges determined in the validation reports (if applicable).
Communicates project status updates to management through the use of tracking sheets (Excel or MS Project).
Works alternate hours/shift schedules due to planned business needs.
Works as a member of a team to achieve all outcomes;
Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
**Performs all work in support of our Values**: Collaboration, Courage, Perseverance, and Passion and
Works in a safe manner collaborating as a team member to achieve all outcomes.
**Demonstrate Behaviours that exhibit our organizational Values**: Collaboration, Courage, Perseverance, and Passion.
Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
All other relevant duties as assigned.
Job Requirements
Education
Bachelor degree in Science or Engineering, or equivalent experience.
Knowledge, Skills and Abilities
High level of familiarity with Excel, Word, Access required.
Proven organizational, problem solving, and project and time management skills demonstrated by previous work experience, in order to manage multiple priorities in a fast-paced environment.
Excellent English oral and written communication skills.
Strong interpersonal skills
Experience
Minimum of three to five years in Validation. Experience in sterilization validation, equipment/process qualification is an asset.
Experience in the pharmaceutical, food, or other chemical processing industry, ideally with exposure to compounding, filling/packaging and cleaning/sterilization processes for liquid dose products (sterile ophthalmic and nasals products) is an

  • Analyst, Computer Systems Validation

    5 months ago

    North York, Canada Apotex Inc. Full time

    **About Apotex Inc.** Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...

  • Care Coordinator

    5 months ago

    North York, Canada Home and Community Care Support Services Full time

    **Job Description**: - Are you an experienced registered nurse (BScN), physiotherapist, occupational therapist, social worker, or speech language pathologist seeking a rewarding career that cares for others, in a professional practice that cares for you? You’re looking in the right place.As a - **Ca** **re Coordinator**, you will assess and determine...

  • On Call Weekday Coordinator

    6 months ago

    North York, Canada Kinnect Support Full time

    Kinnect Support Services is a social services partner that provides trained staff support to various organizations in need of relief staff. Our team offers superior support to Agencies, Organizations, and Institutions that work with adolescents’ youth, adults, and seniors who experience behavioral, social, emotional, physical, and psychiatric...

  • Associate, Mts

    3 months ago

    North York, Canada Apotex Inc. Full time

    **About Apotex Inc.** Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...

  • Community Growth Support Coordinator

    6 months ago

    North York, Canada Girl Guides of Canada-Guides du Canada Full time

    Girl Guides of Canada-Guides du Canada (GGC), a national membership-based organization, empowers every girl in Guiding to discover herself and be everything she wants to be. Our mission is to be a catalyst for girls empowering girls. Together, we’re building our vision of _A better world, by girls. _ - GGC is actively searching for a _**Community Growth...

  • Scheduling Coordinator

    2 months ago

    York, Canada ESS Support Services Full time

    **Job Summary** We are seeking a detail-oriented and proactive Scheduling Coordinator to join our team. Reporting to the Director of HR & Culture, the Scheduling Coordinator acts as first point of contact for direct staff with regards to schedules, call-in and open shifts. Ensures direct staff schedules are completed to meet the need of our clients and the...

  • Sales Support Coordinator

    5 months ago

    North York, Canada Emirates Full time

    JOB PURPOSE Coordinate the Sales Support Team to initiate sales activities in the country considering the different sales channels based on the analysis and evaluation of market-specific data. Identify opportunities and threats in sales (existing business, new business, online, groups) and will support in driving all processes at the organization. Account...

  • Administrative Assistant

    2 weeks ago

    North York, Canada Kinnect Support Full time

    **Company Name: Kinnect Support Service** **Job mission statement & description**: Kinnect Support Services is a small business rapidly growing in the Health Care Industry searching for individuals who are passionate about the well-being and treatment people receive in our community. We work with Agencies to support youth and adult mental health, physical...

  • Warehouse Coordinator

    6 months ago

    North York, Canada Black & McDonald Limited Full time

    **ABOUT THIS CAREER OPPORTUNITY** Black & McDonald's Southern Ontario Utilities team is growing! If you are an independent, enthusiastic, and driven professional searching for an opportunity to build a solid foundation for your career, this position is for you. The Inventory Coordinator is located on site and typically reports directly to the Project...

  • Dz Driver(Valid Moffett/manitou License)

    6 months ago

    North York, Canada The Restorer Inc. Full time

    **Job description** We are looking for a **DZ license driver, with Manitou license** who can start immediately in North York area. Applicants should be a highly organized, energetic individual and looking to work long term. The Delivery Driver role has many diverse and interesting responsibilities, the primary ones are outlined below: ❖ Ensure correct...

  • Property Maintenance Helper

    6 months ago

    North York, Canada Custodia Seniors Support Full time

    What we're looking for: Become a Custodia Staff Home Pro or Home Helper and help local seniors live a better life in their homes. You will be helping them with the lawn, garden, yard, windows, gutters, and general home maintenance. **Responsibilities**: - You will ride along with a Home Manager in a Custodia truck and perform work projects and odd jobs for...

  • Dz Driver(with Valid Moffett/manitou License)

    6 months ago

    North York, Canada The Restorer Inc. Full time

    **Job description** We are looking for a **DZ license driver, with Manitou license** who can start immediately in North York area. Applicants should be a highly organized, energetic individual and looking to work long term. The Delivery Driver role has many diverse and interesting responsibilities, the primary ones are outlined below: ❖ Ensure correct...

  • Facilities Coordinator

    6 months ago

    North York, Canada Lumacare Full time

    Client & Family-Centered Care Is at The Heart of Everything We Do at Lumacare! Lumacare believes Client and Person-Centered Care is based on a philosophy of care, treatment and support that empowers Clients to be active and knowledgeable partners in their health care. Whether you join Lumacare in a client facing role, in a leadership capacity, or in a...

  • Director-quality, Communications

    5 months ago

    York, Canada ESS Support Services Full time

    **Job Summary** Reporting to the CEO**, **the Director of Quality, Communications & Community Outreach is an integral part of the senior management team at ESS Support Services. Oversees the overall development, implementation and monitoring of the quality improvement plans and initiatives at ESS, monitors quality indicators and other quality...

  • Lawn Maintenance Contractor Well Paid

    5 months ago

    North York, Canada Custodia Seniors Support Full time

    _Lawn Maintenance Contractor | Well Paid_ **About us** Backed by the drive to help his mom conserve live a stress-free life at home, Geoff Whitlock set out to create Custodia. In late 2018, he did not know how impactful Custodia was going to be, but he knew exactly what it shouldn’t be; a company that desired profits more than the need to help older...

  • Human Resources Coordinator

    5 months ago

    North Bay, Canada Ontario Aboriginal Housing Support Services Full time

    **Position**: Human Resources Coordinator **Closing**:Posting will remain open until filled **Term**:Full-Time (35 hours per week) permanent **Salary Range**:$45,400- $53,360 Our Vision is “to lead the design, development, and delivery of sustainable and culturally appropriate housing that promotes excellence in the Indigenous community and...

  • HR Coordinator

    1 month ago

    North York, Canada Lumacare Full time

    Person & Family - Centered Care Is at The Heart of Everything We Do at Lumacare! Lumacare believes Person and Family - Centered Care is based on a philosophy of care, treatment and support that empowers Clients to be active and knowledgeable partners in their health care. Whether you join Lumacare in a client facing role, in a leadership capacity, or in a...

  • Administrative Coordinator, North York On

    5 months ago

    North York, Canada Hobart Canada Full time

    **Administrative Coordinator for Sales Department** **Company Information** Hobart is the leading supplier of equipment, systems and service in the food industry. Hobart offers the broadest line of equipment including cooking, food preparation, refrigeration, bakery systems, warewashing and waste systems, and weighing, wrapping and labeling systems. Hobart...

  • Project Coordinator

    6 months ago

    North York, Canada CAPTAIN HANDY INC Full time

    We are currently looking for a highly organized Project Coordinator to oversee all aspects of our landscaping, construction and renovation projects. **Responsibilities**: - Locate vendors of materials, equipment or supplies and determine product availability and terms of sales, best prices and negotiate the best deals - Place orders of supplies, materials...

  • Warehouse Coordinator

    5 months ago

    North York, Canada Woodgrove Technology Inc. Full time

    **Warehouse Coordinator - Woodgrove Technologies Inc.** **About Us** We are a leading provider of energy efficient, cutting edge equipment, instrumentation, and process control systems to the global mining industry. With companies in Brazil, Chile, Mexico and South Africa, Woodgrove has built a reputation based on quality, performance and safety. The...