ClinChoice is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our customers. ClinChoice was established in the US in 1995, and has grown to more than 2,000 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region. Please visit our website ClinChoice.com for our company information.

DUTIES & RESPONSIBILITIES:

This position is responsible for ensuring compliance to Canadian GMP regulations for all products released for sale to the Canadian market.

Key Responsibilities:

Manage Quality Operations responsibilities associated with product release including but not limited to:

• Review of 3PL documentation
• Review of Quality documentation
• Disposition of imported and domestic product
• Communicate and collaborate with 3PL on issues, deviations and corrective/preventative actions related to product distributed in Canada.
• Communicate and collaborate with Quality Associates/Specialists/Sr. Specialists and manufacturing sites on issues, deviations and corrective/preventative actions related to product distributed in Canada.
• Communicate and collaborate with laboratories to ensure the product is tested and results are provided in a timely manner.
• Communicate any issues that could impact product supply to Quality Operations partners.
• Manage and maintain all quality documents.
• Manage Quality Operations responsibilities associated with product compliance including but not limited to review and/or approval of compliance documentation such as APQR, Batch records, stability data, master manufacturing/packaging documentation.
• Provide review and support of tasks related to launching of new products, as required.
• Support Quality Operations team, as required to ensure products are launched in a timely manner.
• Review and reporting of Quality Operations KP

Experience & Qualifications:

• Bachelor's degree in science (Chemistry, Biology, Chemistry, Biology, Engineering or Pharmaceutical Quality Assurance) or Bachelor of Science with additional post-graduate training and certification in Quality Control/Quality Assurance
• 3-5 years of experience is required however, 5-10 years is preferred.

• Excellent knowledge of GMPs and Health Canada regulations for drug products, biologics and medical devices
• Prior Quality Assurance experience in the Pharmaceutical or Medical Device Industry
• Drug and/or medical device product release/product disposition experience
• Experience reviewing master and executed manufacturing/packaging documentation.
• Prior experience reviewing and approving compliance documentation.
• Previous experience working with a 3PL.
• Previous experience with Corporate and/or MoH audits
• Experience with laboratory methods and method transfers
• Strong decision-making skills,
• Detail oriented with the ability to work under pressure.
• Ability to build strong relationships with internal and external customers.
• Excellent communication skills
• Ability to manage multiple projects and priorities.
• Ability to deal with ambiguous situations.
• Excellent project management