Kelly Services Senior Quality Assurance Associate - Pharma in Hamilton, Canada

Kelly Scientific Resources (KSR) is a specialty service of Kelly Services, Inc., a leader in providing workforce solutions. Since its launch in 1995, KSR has provided staffing and placement services to a broad spectrum of industries, including biotechnology, chemical, consumer products, cosmetics, environmental, food sciences, medical/clinical, pharmaceutical, and petrochemical. Today, KSR leads the world in dedicated scientific and clinical research staffing. Visit www.kellyscientific.com to learn more and view a full listing of our opportunities.

SENIOR QUALITY ASSURANCE ASSOCIATE - Pharma

Responsibilities:

  • Ensure GMP compliance during validation activities

  • Review of non-conformance reporting and investigations, following up with CAPAs and change controls

  • Act as quality contact and participate in team meetings to provide QA updates and address any issues as required

  • Acquire an understanding of manufacturing processes in order to develop approaches that ensure relevant standards are being met.

  • Review SOPs, MBRs, STMs and other controlled documents for compliance with regulations and propose changes for review and approval

  • Review and approve specifications for incoming raw materials and finished products

  • Review validation and stability protocols and reports for compliance with quality system and regulatory requirements

  • Support validation activities including review of executed batch records and testing data for compliance, as well as reviewing OOS, non-conformances,

  • Change Controls and CAPAs

  • Support maintenance and improvement of the Quality Systems

  • Participate in regulatory and client GMP inspections

  • Conduct relevant internal training of staff where needed

  • Assist with building the Quality System according to Health Canada and FDA regulations, ICH Q10 and ISO guidance

Requirements:

  • BSc in Chemistry, Life Sciences or related field

  • 5+ years’ experience working in a pharmaceutical or GMP environment

  • Up-to-date on quality management trends and developments

  • In-depth knowledge of key regulations pertinent to Product Development and Quality

  • Flexibility in work schedule to support a 24/7 production environment