Quality & Compliance Specialist, Analytical Services

5 days ago

Aurora, Canada Piramal Healthcare Full time

At **Piramal Healthcare**, we make life changing, lifesaving medications. We believe that by bringing the best-in-class talent on board—and providing cutting-edge growth and learning opportunities—we are creating a positive impact on patients, customers, and the communities we serve. Thus, we offer our employees an abundance of learning opportunities for their full potential to build upon.

**JOB PURPOSE**:
Provide assurance that all data generated from the analytical laboratories AS are accurate, complete and in compliance with data integrity, current Good Manufacturing Practices (CGMP), clients and regulatory agency requirements. Maintains quality and compliance by identifying quality requirements, disseminating standards, policies, and procedures and recommending improvement plans.

**JOB RESPONSIBILITIES**:

- Review all analytical data generated by the Analytical Services laboratory including but not limited to products, method validations, method transfers, stability studies, standard qualifications, R&D samples (as applicable) and any third party samples for accuracy, completeness and compliance to data integrity, written procedures and CGMP regulations
- Review all planned and unplanned deviations for accuracy, completeness and compliance to data integrity, written procedures and CGMP regulations
- Provide analyst and client correspondence on data corrections and reports LIMS release of all tests and samples listed above
- Preparation of stability, standard, validation protocols and other technical documents
- Provide analyst feedback for completion of various reports
- Ensure compliance with internal approved procedures, specifications and protocols of all generated data
- Ensure timely completion of all data review
- Filing of request forms, runlogs, lab numbers and other lab documentation, as required
- Review out-of-specifications, analytical deviations, investigations and run log summaries
- Create and revise Certificates of Analysis and other technical documents as required
- Revise via change control documentation as required
- Participate in the implementation of continuous improvement initiatives as they relate to quality activities (e.g., introduction of new technology and automation with respect to data acquisition, electronic review, quality management systems, LIMS, tracking project spreadsheets, etc.)
- Participate in internal and external audits
- Provide data and information pertaining to lab or systems for internal or external clients as requested
- Perform other related assignments and projects as required

**EDUCATIONAL AND PROFESSIONAL ATTAINMENT**:

- B.Sc. degree in Chemistry or related science

**JOB RELATED WORK EXPERIENCE REQUIRED**:

- 2 years related experience and within the pharmaceutical industry preferred.
- Commensurate with education (approx. 2 or more yrs. with B.Sc.; approx. 5 or more yrs. with post-secondary school education)
- Knowledge of relevant regulations and guidance required to ensure site compliance
- Knowledge of relevant regulations and guidance required to ensure site compliance

**SKILLS AND KNOWLEDGE**:

- Good knowledge of CGMP requirements, ICH, FDA guidelines
- Knowledge of analytical instrumentation and techniques
- Skills in interpreting and trending analytical data and instrumentation/equipment software (Empower and stand alone instruments)
- Understanding of method development, validation, transfer and stability requirements
- Strong communication skills, both written and verbal
- Extensive knowledge of compliance in the pharmaceutical manufacturing processes (API)

**CRITICAL ATTRIBUTES**:

- EHS Focus
- Passionately Reliable
- Rapid Responsiveness
- Innovative Efficiency
- Teamwork
- Detail Orientation

**Piramal Pharma Solutions **is an equal opportunity employer. We prohibit discrimination based on age, color, disability, national origin, race, religion, sex, sexual orientation, and any other legally protected class in accordance with applicable federal, provincial and local laws. We are also committed to creating and maintaining an inclusive and accessible workplace. If you are contacted to be part of our recruitment process and require accommodation during it, please let us know.

**Job Types**: Full-time, Permanent

Ability to commute/relocate:

- Aurora, ON L4G 4C3: reliably commute or plan to relocate before starting work (required)

Work Location: In person

  • Compliance Specialist

    5 days ago

    Aurora, Canada Bulk Barn Full time

    About Us Established in 1982, Bulk Barn is Canada's largest bulk food retailer with close to 300 stores and growing! The key to our success is progressive thinking, detailed/ methodical planning and flawless execution by passionate people across our organization. We strive to foster a balanced and flexible culture that benefits both our customers and...

  • Compliance Specialist

    7 days ago

    Aurora, Canada Bulk Barn Full time

    About Us Established in 1982, Bulk Barn is Canada's largest bulk food retailer with close to 300 stores and growing! The key to our success is progressive thinking, detailed/ methodical planning and flawless execution by passionate people across our organization. We strive to foster a balanced and flexible culture that benefits both our customers and...

  • Compliance Specialist

    1 week ago

    Aurora, Ontario, Canada Bulk Barn Full time

    About UsEstablished in 1982, Bulk Barn is Canada's largest bulk food retailer with close to 300 stores and growing The key to our success is progressive thinking, detailed/ methodical planning and flawless execution by passionate people across our organization. We strive to foster a balanced and flexible culture that benefits both our customers and...

  • Analytical Services Analyst

    4 weeks ago

    Aurora, Canada Piramal Healthcare Full time

    **Analytical Services Analyst** **JOB PURPOSE**: Perform lab testing to high standards of quality and efficiency in support of our customers and our production facilities. **JOB RESPONSIBILITIES**: - Independent execution and troubleshooting of analytical activities related to projects as provided by the AS Manager or senior member - Effectively...

  • Compliance Analyst

    1 week ago

    Aurora, Ontario, Canada Magna International Inc. Full time

    Group DescriptionAt Magna, we create technology that disrupts the industry and solves big problems for consumers, our customers, and the world around us. We're the only mobility technology company and supplier with complete expertise across the entire vehicle.We are committed to quality and continuous improvement because our products impact millions of...

  • Quality Control Specialist

    1 week ago

    Aurora, Canada Canadian Medical Products Inc. Full time

    Job Summary: **Duties**: - Perform quality control inspections on incoming materials, in-process production, and finished products - Conduct visual inspections to identify defects or deviations from specifications - Collaborate with the Quality Management team to implement corrective actions - Maintain accurate records of inspections and testing results -...

  • Payroll Specialist

    3 weeks ago

    Aurora, Canada Matheson Constructors Full time

    **Date Posted**: - 05/15/2024**Location**: - Aurora, ON**Salary Interval**: - Full-Time Permanent**Pay Range**: - N/A**Application Instructions** Please complete in one session. **Position Description** Matheson Constructors is a leading construction firm focused on delivering exceptional construction management, general contracting, design-build, and...

  • Manager of Clinic Services

    2 weeks ago

    Aurora, Canada Enhanced Care Clinic Full time

    At Enhanced Care, we know the importance of primary care and family practice in everyone's health and wellness. With a team of skilled individuals working alongside with over 70 family physicians, specialists, and allied health providers, our goal is to get our patients healthy, quickly and safely. **Summary**: Manager of Clinic Services is responsible for...

  • Accounts Payable Specialist

    2 months ago

    Aurora, Canada Environmental 360 Solutions Full time

    **Company Overview** Founded in 2018, Environmental 360 Solutions (E360S) is dedicated to becoming one of North America's leading and most trusted environmental management companies. Growing through acquisition and organically, E360S provides environmental and waste management solutions to municipalities, commercial and residential customers. **Position...

  • Accounts Payable Specialist

    3 weeks ago

    Aurora, Canada Environmental 360 Solutions Full time

    **Company Overview** Founded in 2018, Environmental 360 Solutions (E360S) is dedicated to becoming one of North America's leading and most trusted environmental management company’s. Growing through acquisition and organically, E360S provides environmental and waste management solutions to municipalities, commercial and residential customers. **Position...

  • Accounts Payable Specialist

    2 weeks ago

    Aurora, Canada Environmental 360 Solutions Full time

    **Company Overview** Founded in 2018, Environmental 360 Solutions (E360S) is dedicated to becoming one of North America's leading and most trusted environmental management companies. Growing through acquisition and organically, E360S provides environmental and waste management solutions to municipalities, commercial and residential customers. **Position...

  • Documentation and Funding Specialist

    4 weeks ago

    Aurora, Canada Volvo Group Full time

    **Documentation & Funding Specialist** **Ready to shape tomorrow’s society with us?** At Volvo Financial Services (VFS), we believe that relationships, hard work, and technological innovation will lead the way into the future to keep our customers and employees connected, successful, and moving forward. As a **Documentation & Funding Specialist**, you...

  • Manager of Clinic Services

    2 weeks ago

    Aurora, Ontario, Canada Enhanced Care Clinic Full time

    At Enhanced Care, we know the importance of primary care and family practice in everyone's health and wellness. With a team of skilled individuals working alongside with over 70 family physicians, specialists, and allied health providers, our goal is to get our patients healthy, quickly and safely.Summary: Manager of Clinic Services is responsible for direct...

  • Application Specialist

    1 week ago

    Aurora, Ontario, Canada JANA Corporation Full time

    Salary:APPLICATION SPECIALIST IJANA's Application Specialists install, configure, manage, and troubleshoot JANA's software products based on client requirements and model calibration. They will identify and analyze I.T. problems and needs for the clients and then develop appropriate solutions. Application Specialists will provide technical support,...

  • Application Specialist

    2 weeks ago

    Aurora, Canada JANA Corporation Full time

    Salary: APPLICATION SPECIALIST I JANA's Application Specialists install, configure, manage, and troubleshoot JANA's software products based on client requirements and model calibration. They will identify and analyze I.T. problems and needs for the clients and then develop appropriate solutions. Application Specialists will provide technical support,...

  • Application Specialist

    3 weeks ago

    Aurora, Canada JANA Corporation Full time

    APPLICATION SPECIALIST I JANA’s Application Specialists install, configure, manage, and troubleshoot JANA’s software products based on client requirements and model calibration. They will identify and analyze I.T. problems and needs for the clients and then develop appropriate solutions. Application Specialists will provide technical support, diagnosing...

  • Quality Control Analyst Ii

    5 days ago

    Aurora, Canada Piramal Healthcare Full time

    At **Piramal Healthcare**, we make life changing, lifesaving medications. We believe that by bringing the best-in-class talent on board—and providing cutting-edge growth and learning opportunities—we are creating a positive impact on patients, customers, and the communities we serve. Thus, we offer our employees an abundance of learning opportunities for...

  • Manager of Clinic Services

    7 days ago

    Aurora, Canada Enhanced Care Clinic Full time

    **Summary**: Manager of Clinic Services is responsible for direct contribution of day to day tasks, supervision of on-site and virtual clinic service delivery. **Reports to**:Sr Manager Operations, Managing Director **Locations**:Aurora Yonge (14872 Yonge Street, Aurora ON L4G1N2) Aurora East (25 William Graham Drive, Aurora ON L4G...

  • Payroll Specialist

    1 week ago

    Aurora, Ontario, Canada Matheson Constructors Full time

    Date Posted: 03/08/2023Location: Aurora, ONSalary Interval: Full-Time PermanentApplication InstructionsPlease complete in one session.Position DescriptionMatheson Constructors is a leading construction firm focused on delivering exceptional construction management, general contracting, design build and public-private partnerships.We are committed to hirign...

  • Quality Manager

    2 months ago

    Aurora, Canada JANA Corporation Full time

    QUALITY MANAGER JANA has a progressive culture of personal and professional growth. With a vested interest in each employee’s professional growth and continuous improvement as an individual, JANA supports professional development, continuous education, industry participation and technical accreditations. Other Perks that come with joining the JANA Family...