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QA Validation Associate

job details

summary

    job details
    Are you an expert in providing quality validation support for new and existing product development initiatives, including process validation, cleaning validation and troubleshooting?
    Do you have good knowledge and experience in operations and processes of compliance with Health Canada GMP & FDA cGMP regulations?

    If so then this could be a great opportunity for you!

    Our client, who is a global manufacturer of household cleaning supplies and other consumer chemicals in the Brantford area is looking to hire a QA Validation Associate with thorough knowledge of applicable regulatory standards as it relates to GMP / cGMP and GLP. We are looking for bout 2 years of experience as a quality engineer or quality assurance/control, validation or related role in a pharmaceutical manufacturing industry, GMP/cGMP environment with hands-on experience in the use of Gas Chromatograph (GC), High-Performance Liquid Chromatograph (HPLC), and other common laboratory equipment is required.

    This is a 6 months contract (with possible extension or hire)

    Advantages
    Global brand
    work in a world-class facility
    competitive pay
    vacation pay
    lots of opportunity to learn and grow


    Responsibilities
    Responsibilities include method validation, process validation, cleaning validations, stability testing, developing quality control systems, and determining corrective actions. You will also work with managers and supervisors to implement quality measures. A successful QA Validation Associate should have excellent troubleshooting skills and be able to ensure that processes and products consistently meet established quality standards.

    The successful candidate demonstrates a strong knowledge of electronic systems including MS Word and MS Excel, is highly motivated, a self-starter, and able to work with a team on projects as well as on their own. The position requires the execution of multiple projects at the same time and good communication skills to keep peers and management up to date with progress of all projects in order to ensure projects are completed in a timely manner and on schedule.

    • Provide quality support for NPD/EPD projects including but not limited to stability testing and various validation activities.
    • Develop validation protocols for equipment qualification, facility qualification, cleaning validation, process validation and computerized system qualification and generate final report.
    • Perform required stability testing for EPD projects
    • Conduct method validation and cleaning validation activities relating to EPD projects
    • Maintain and update Master Validation/Qualification Plan.
    • Maintain calibration & PM program, contact contractor for calibration activities to ensure all equipment are within calibration and monitor PM program for compliance.
    • Develop and implement standard operating procedures in support of quality systems at SCJ-Pro
    • Support the administration, review and approval of key quality management system (QMS) documents including Deviation Reports, Change Controls, CAPA, Complaint Investigations and Training
    • Communicates regularly with production and QA staff to allow other departments to effectively plan their activities.
    • Assist in the writing of validation aspect of Annual Product Quality Reports (APQRs) for product consistency regarding their quality, including the deviations, change controls and customer complaints.

    Qualifications
    Bachelor’s degree in science, engineering or a related field, obtained through an accredited university; master’s degree preferred
    • Certification as CQE (Certified Quality Engineer) from the American Society for Quality is an asset, but not required
    • 2+ years of experience as a quality engineer, quality assurance/control, validation or related role in a pharmaceutical manufacturing industry, GMP/cGMP environment required.
    • Experience in the use of Gas Chromatograph (GC), High-Performance Liquid Chromatograph (HPLC), and other common laboratory equipment is required
    • Thorough knowledge of applicable regulatory standards as it relates to GMP / cGMP and GLP.
    • Proficient knowledge of electronic systems including MS Word and MS Excel
    • The ability to multitask and manage time effectively to ensure all work streams are managed
    • Emotional resilience and an ability to work under pressure with a "can-do attitude"
    • Ability to process a high volume of planned and unplanned work effectively
    • A determination to continually develop and improve existing processes
    • Strong interpersonal skills required to effectively liaise with manufacturing staff, administration staff and external contacts.
    • Excellent verbal and written communication skills in dealing/corresponding with outside contacts and internal staff.
    • Good judgement and problem-solving skills are necessary when dealing with results that require modifications/resolving.

    Summary
    If this sounds like an opportunity that you are looking for then please apply online or send your resume to Dev Sandhu at dev.sandhu@randstad.ca

    **Only qualified candidates will be contacted

    Please visit www.randstad.ca for a complete list of open positions.

    Randstad Canada is committed to fostering a workforce reflective of all peoples of Canada. As a result, we are committed to developing and implementing strategies to increase the equity, diversity and inclusion within the workplace by examining our internal policies, practices, and systems throughout the entire lifecycle of our workforce, including its recruitment, retention and advancement for all employees. In addition to our deep commitment to respecting human rights, we are dedicated to positive actions to affect change to ensure everyone has full participation in the workforce free from any barriers, systemic or otherwise, especially equity-seeking groups who are usually underrepresented in Canada's workforce, including those who identify as women or non-binary/gender non-conforming; Indigenous or Aboriginal Peoples; persons with disabilities (visible or invisible) and; members of visible minorities, racialized groups and the LGBTQ2+ community.

    Randstad Canada is committed to creating and maintaining an inclusive and accessible workplace for all its candidates and employees by supporting their accessibility and accommodation needs throughout the employment lifecycle. We ask that all job applications please identify any accommodation requirements by sending an email to accessibility@randstad.ca to ensure their ability to fully participate in the interview process.
    Are you an expert in providing quality validation support for new and existing product development initiatives, including process validation, cleaning validation and troubleshooting?
    Do you have good knowledge and experience in operations and processes of compliance with Health Canada GMP & FDA cGMP regulations?

    If so then this could be a great opportunity for you!

    Our client, who is a global manufacturer of household cleaning supplies and other consumer chemicals in the Brantford area is looking to hire a QA Validation Associate with thorough knowledge of applicable regulatory standards as it relates to GMP / cGMP and GLP. We are looking for bout 2 years of experience as a quality engineer or quality assurance/control, validation or related role in a pharmaceutical manufacturing industry, GMP/cGMP environment with hands-on experience in the use of Gas Chromatograph (GC), High-Performance Liquid Chromatograph (HPLC), and other common laboratory equipment is required.

    This is a 6 months contract (with possible extension or hire)

    Advantages
    Global brand
    work in a world-class facility
    competitive pay
    vacation pay
    lots of opportunity to learn and grow


    Responsibilities
    Responsibilities include method validation, process validation, cleaning validations, stability testing, developing quality control systems, and determining corrective actions. You will also work with managers and supervisors to implement quality measures. A successful QA Validation Associate should have excellent troubleshooting skills and be able to ensure that processes and products consistently meet established quality standards.

    The successful candidate demonstrates a strong knowledge of electronic systems including MS Word and MS Excel, is highly motivated, a self-starter, and able to work with a team on projects as well as on their own. The position requires the execution of multiple projects at the same time and good communication skills to keep peers and management up to date with progress of all projects in order to ensure projects are completed in a timely manner and on schedule.

    • Provide quality support for NPD/EPD projects including but not limited to stability testing and various validation activities.
    • Develop validation protocols for equipment qualification, facility qualification, cleaning validation, process validation and computerized system qualification and generate final report.
    • Perform required stability testing for EPD projects
    • Conduct method validation and cleaning validation activities relating to EPD projects
    • Maintain and update Master Validation/Qualification Plan.
    • Maintain calibration & PM program, contact contractor for calibration activities to ensure all equipment are within calibration and monitor PM program for compliance.
    • Develop and implement standard operating procedures in support of quality systems at SCJ-Pro
    • Support the administration, review and approval of key quality management system (QMS) documents including Deviation Reports, Change Controls, CAPA, Complaint Investigations and Training
    • Communicates regularly with production and QA staff to allow other departments to effectively plan their activities.
    • Assist in the writing of validation aspect of Annual Product Quality Reports (APQRs) for product consistency regarding their quality, including the deviations, change controls and customer complaints.

    Qualifications
    Bachelor’s degree in science, engineering or a related field, obtained through an accredited university; master’s degree preferred
    • Certification as CQE (Certified Quality Engineer) from the American Society for Quality is an asset, but not required
    • 2+ years of experience as a quality engineer, quality assurance/control, validation or related role in a pharmaceutical manufacturing industry, GMP/cGMP environment required.
    • Experience in the use of Gas Chromatograph (GC), High-Performance Liquid Chromatograph (HPLC), and other common laboratory equipment is required
    • Thorough knowledge of applicable regulatory standards as it relates to GMP / cGMP and GLP.
    • Proficient knowledge of electronic systems including MS Word and MS Excel
    • The ability to multitask and manage time effectively to ensure all work streams are managed
    • Emotional resilience and an ability to work under pressure with a "can-do attitude"
    • Ability to process a high volume of planned and unplanned work effectively
    • A determination to continually develop and improve existing processes
    • Strong interpersonal skills required to effectively liaise with manufacturing staff, administration staff and external contacts.
    • Excellent verbal and written communication skills in dealing/corresponding with outside contacts and internal staff.
    • Good judgement and problem-solving skills are necessary when dealing with results that require modifications/resolving.

    Summary
    If this sounds like an opportunity that you are looking for then please apply online or send your resume to Dev Sandhu at dev.sandhu@randstad.ca

    **Only qualified candidates will be contacted

    Please visit www.randstad.ca for a complete list of open positions.

    Randstad Canada is committed to fostering a workforce reflective of all peoples of Canada. As a result, we are committed to developing and implementing strategies to increase the equity, diversity and inclusion within the workplace by examining our internal policies, practices, and systems throughout the entire lifecycle of our workforce, including its recruitment, retention and advancement for all employees. In addition to our deep commitment to respecting human rights, we are dedicated to positive actions to affect change to ensure everyone has full participation in the workforce free from any barriers, systemic or otherwise, especially equity-seeking groups who are usually underrepresented in Canada's workforce, including those who identify as women or non-binary/gender non-conforming; Indigenous or Aboriginal Peoples; persons with disabilities (visible or invisible) and; members of visible minorities, racialized groups and the LGBTQ2+ community.

    Randstad Canada is committed to creating and maintaining an inclusive and accessible workplace for all its candidates and employees by supporting their accessibility and accommodation needs throughout the employment lifecycle. We ask that all job applications please identify any accommodation requirements by sending an email to accessibility@randstad.ca to ensure their ability to fully participate in the interview process.