Title: Quality Compliance Specialist
Location: Mississauga, ON
Roche is seeking a Compliance Specialist to source, maintain and approve master documentation for the purpose of ensuring all Roche Canada products are in compliance with Regulatory market authorization. The incumbent will be responsible for writing and maintaining SOP’s, local GMP agreements, and other Quality documents. He/she will ensure that Roche Canada Quality Operations is in compliance with GMP regulations
Source, approve and maintain, through the use of Change Control systems and documentation, all required master documentation (production and packaging masters, drug product and packaging component specs and methods, validation, etc.) from local 3rd party sites.
Write and review Canadian APQRs
Review and release commercial drug batches in compliance with their respective product specifications
Review and release clinical drug batches in compliance with their respective CTA and product specifications
Investigate, document and respond to product quality customer complaints as per Health Canada regulations and local SOP’s
Write, and provide content assessment for GMP agreements issued by Roche Canada as per Health Canada guidelines
Maintain relationships with local manufacturers, distributors and warehouses
Bachelor’s degree preferably in a Science discipline (Chemistry, biology, pharma production)
3-5 years of experience in a QA/QC Pharmaceutical manufacturing environment
Strong knowledge of GMP and ability to implement practical solutions
Excellent communication and strong technical writing skills
Strong MS Office proficiency (Word, Excel, Visio)
Qualified candidates are encouraged to submit cover letter and resume no later than September 23, 2019.
This position is not eligible for relocation support.
This position is open to applicants legally authorized to work in Canada.
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process
AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.