Associate, Quality

2 weeks ago


Mississauga, Canada Hikma Pharmaceuticals PLC Full time

Summary:
The Quality and Regulatory Associate will have the primary responsibility of supporting the approval, post-approval maintenance, import and distribution of sterile drug products. The individual will be a change agent with experience strengthening Quality Systems and processes across all departments of the company and building Quality relationships with business partners. The Associate will support the Quality and Regulatory departments in the activities of submissions (Health Canada and formulary), labelling, document control, batch review, product release, complaints, CAPAs and compliance, including Change Control and post-market submission and vigilance activities for the Canadian site.

Reporting Relationships:

- Quality Assurance and Regulatory Departments
- Intercompany Affiliates Departments
- Warehouse Operations and Quality
- Contract Third Party Business Partners
- Other company divisions as needed and required by the position

Responsibilities & Duties:
Key Responsibility: Quality Assurance (50%)

The key responsibilities and duties for which the Quality Associate will be responsible include, but are not limited to:

- Drafting, evaluating, and reviewing Annual Product Quality Reports for adverse trends and compliance.
- Tracking stability lots and timepoints and entering stability data into Stability program
- Reviewing batch records, product specifications, Certificates of Compliance, Certificates of Analysis, and all other supporting documentation toward the release of product to the Canadian market.
- Ensuring document control and maintenance of electronic and hard copy GMP records according to company policies and practices
- Assisting in the investigation, review and disposition of product returns, destructions, and recalls.
- Reviewing of compendia for monograph updates and revision to specifications, where necessary.
- Investigating both individually and as a team member, product complaints, adverse events, deviations, and OOS results to determine product impact, root cause and corrective/preventative actions.
- Supporting the change control process of Quality System Records as required to maintain GMP compliance.
- Maintaining and updating Quality Dossiers and records.
- Preparing and reviewing mock labelling for new products and coordinate changes with graphic artist and managing the GS1 database.
- Assisting in the systematic audit of on-site and off-site activities to determine if in compliance.
- Ensuring ongoing compliance with local, national, and international standards and legislation.
- Other duties as required

Key Responsibility: Regulatory Affairs (50%)
- Assist in preparation of pre-market and post-market dossiers for drugs for submission to Health Canada.
- Prepare and review product labels and promotional materials.
- Monitor Health Canada’s Product Monograph Brand Safety Updates.
- Ensure post-approval regulatory compliance of marketed drug products meeting company’s and regulatory requirements.
- Prepare and review provincial formulary submissions.
- Other duties as required.

Qualifications:

- BSc in Chemistry, Pharmacy or other Life Science from a Canadian University or a degree recognized as equivalent by a Canadian university or Canadian accreditation body
- Minimum 1 year in a quality or regulatory role working in the pharmaceutical industry.
- Demonstrated knowledge of TPD, ICH Guidelines, GMPs, regulations and other relevant policies
- Strong written and verbal communication skills
- Excellent organization, time management and prioritization skills
- Works well under pressure in a team-based environment
- Meticulous and detail-oriented with strong work ethic
- Sound problem solving and decision-making abilities
- Works independently and accomplishes tasks without supervision
- Proficient user of Microsoft Office products
- Bilingual in French and English is an asset

This description outlines the principal functions of the job identified and should not be considered a detailed description of all requirements that may be inherent in the job.



  • Mississauga, Canada HelloFresh Full time

    **Location**: Tomken Rd & Matheson Blvd East, Mississauga, ON **Pay**: $20.25/ hour **Shift**:Sunday-Wednesday, 8:00am-6:45 including weekends & holidays **About the Role** As a Quality Control Associate you will take a hands-on approach to maintaining and continuously improving our product quality control processes. Reporting to the Production Team...


  • Mississauga, Canada Mako Plastics Ltd. Full time

    We are currently seeking a reliable Inventory/Quality Control Associate. The ICA is responsible for direct examination of products to ensure that quality standards and procedures are met and aligned with legislation and customer specifications. Requiring a high level of attention to detail, the Quality Control Associate is responsible for strictly adhering...


  • Mississauga, Canada Seaford Pharmaceuticals Inc. Full time

    Under the direction of the department manager, the Quality and Compliance Associate is responsible to carry out Quality Assurance functions at Seaford Pharmaceuticals to ensure compliance with all regulatory requirements applicable to Seaford’s operations. The Quality and Compliance Associate will provide oversight and guidance in matters of Quality and...


  • Mississauga, Ontario, Canada Seaford Pharmaceuticals Inc. Full time

    Under the direction of the department manager, the Quality and Compliance Associate is responsible to carry out Quality Assurance functions at Seaford Pharmaceuticals to ensure compliance with all regulatory requirements applicable to Seaford's operations.The Quality and Compliance Associate will provide oversight and guidance in matters of Quality and...


  • Mississauga, Canada Quest Window Systems Inc Full time

    **Get to know us** Quest Window Systems Inc (“Quest”) is a manufacturer of a window wall system designed for high-rise residential developments, based in Toronto, Ontario Canada. Quest services clients from all over North America, including major metropolises such as New York, Los Angeles, Washington DC, and Toronto. **Purpose** This position is...


  • Mississauga, Canada HelloFresh Full time

    At HelloFresh, we want to change the way people eat forever by offering our customers high quality food and recipes for different meal occasions. Over the past 10 years, we've seen this mission spread around the world and beyond our wildest dreams. Now, we are a global food solutions group and the world's leading meal kit company, active in 18 countries...


  • Mississauga, Canada Church & Dwight Full time

    A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take...


  • Mississauga, Ontario, Canada HelloFresh Full time

    At HelloFresh, we want to change the way people eat forever by offering our customers high quality food and recipes for different meal occasions. Over the past 10 years, we've seen this mission spread around the world and beyond our wildest dreams. Now, we are a global food solutions group and the world's leading meal kit company, active in 18 countries...


  • Mississauga, Ontario, Canada BD Full time

    Job Description Summary:SUMMARYThe Quality Management Associate (QMA) has the responsibility and authority for assisting Quality Management in the routine oversight and operation of the Quality related matters within the Distribution Center (DC). This position is also responsible for ensuring that BD - Canada complies with applicable regulations including...


  • Mississauga, Canada Resilience Full time

    JOB SUMMARY: Ready to join a team dedicated to quality excellence, innovation and the advance of complex medicine manufacturing supporting patients worldwide? Are you an architect at heart and love designing and developing systems and processes from the ground up? We started an incredible journey and are looking for passionate leaders to join us on this...

  • Associate, Quality

    3 weeks ago


    Mississauga, Canada Hikma Pharmaceuticals PLC Full time

    Summary: The Quality and Regulatory Associate will have the primary responsibility of supporting the approval, post-approval maintenance, import and distribution of sterile drug products. The individual will be a change agent with experience strengthening Quality Systems and processes across all departments of the company and building Quality relationships...


  • Mississauga, Ontario, Canada Resilience Full time

    JOB SUMMARY:Ready to join a team dedicated to quality excellence, innovation and the advance of complex medicine manufacturing supporting patients worldwide? Are you an architect at heart and love designing and developing systems and processes from the ground up? We started an incredible journey and are looking for passionate leaders to join us on this...


  • Mississauga, Canada Church & Dwight Full time

    Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the...


  • Mississauga, Ontario, Canada Church & Dwight Full time

    Job Description A collective energy and ambition. A place where you can make a real difference. We're a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the...


  • Mississauga, Ontario, Canada ABL Employment Full time

    Our Client is a World-Class Manufacturer company looking for Quality control associate. If you are a meticulous person, this job is meant for you It's a long term opportunity, Steady days Candidate Must be able to work 40HR/week on SIN * What We Offer:– $680hr/Week plus 4% vacation pay– weekly Pay every Friday– Temp to Hire– Benefits once hired on–...


  • Mississauga, Canada Dr. Reddy's Laboratories Inc Full time

    **At Dr. Reddy's "Good Health Can't Wait"** By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We seek dynamic and energetic...


  • Mississauga, Canada Dr. Reddy's Laboratories, Inc. Full time

    **Description** **At Dr. Reddy's "Good Health Can't Wait"** By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We seek...


  • Mississauga, Ontario, Canada Q&C Full time

    The Associate Consultant—Compliance Services role focuses on applying your GMP knowledge and experience to various projects, such that the client is confident in the approach and timing of execution of the project. Our consultants work independently within a team environment to ensure activities are undertaken in a timely manner. We are looking for...


  • Mississauga, Canada BD Full time

    **Job Description Summary**: SUMMARY The Quality Management Associate (QMA) has the responsibility and authority for assisting Quality Management in the routine oversight and operation of the Quality related matters within the Distribution Center (DC). This position is also responsible for ensuring that BD - Canada complies with applicable regulations...


  • Mississauga, Canada Q&C Full time

    In this broad-based role, you will support the projects assigned to you, meeting the client's needs. The role specifically prioritizes, plans, organizes and executes projects related to quality and compliance of health products to ensure smooth implementations. The role may involve coordinating/working with client personnel to meet project goals. Reporting...