Compliance Specialist - 1 year contract/CDIP (2 positions)

Job description

  Job facts

Job Title: Compliance Specialist
Department: Quality Management
Reports to: Manager, Quality Management

Job Purpose:

Source, maintain and approve master documentation for the purpose of ensuring all Roche Canada products are in compliance with Regulatory market authorization. Write and maintain SOPs, local GMP agreements and other Quality documents. Maintain validation status and ensure that Roche Canada Quality Operations is in compliance with GMP regulations

Job Accountabilities:

• 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 foreign and local 3rd party sites. Review and release drug batches to the Canadian market in compliance with the Regulatory Market Authorization in accordance with GMP regulations and approved master documents (i.e. Production, testing, packaging and labeling).

• Review and release clinical drug batches in compliance with their respective CTA and product specifications

• Maintain all GMP documentation as required by Canadian GMP and Roche Quality systems in an orderly, timely and accurate manner

• Manage and maintain the Drug Establishment Licence for Roche Canada to ensure compliance of all listed foreign sites and drug products.

• Apply industry experience and knowledge to interpret Canadian GMP regulations and guidelines as applicable to Roche Canada Quality systems and manage all aspects (writing, execution, evaluation, conclusions and final reports) of technical studies, CCs and DIRs to support QM compliance decisions, changes and actions.

• Investigate, document and respond to product quality customer complaints as per Health Canada regulations and local SOPs

• Write, and provide content assessment for GMP agreements issued by Roche Canada as per Health Canada guidelines

• Conduct GMP audits of local 3rd party contractors and Roche Canada self inspection audits against GMP regulations, guidelines and agreements

·  Who we are

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees.The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.

Roche is an equal opportunity employer.

Desired profile

Who you are

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Education, Skills, Knowledge, Experience:

• Bachelor's Degree in Science (Chemistry, Biology, Pharmaceutical Production etc.)

• Minimum 2 years of experience with related QC/QA/manufacturing in a pharmaceutical environment

Qualified candidates are encouraged to apply by: December 6, 2017

This position is not eligible for relocation support.

This position is open to applicants legally authorized to work in Canada.

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.

NOTE: All employment is conditional upon completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.

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.
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