Job Description

Summary:

The Quality and Regulatory Associate will have the primary responsibility of supporting the approval, post-approval maintenance, import and distribution of sterile drug products. The individual will be a change agent with experience strengthening Quality Systems and processes across all departments of the company and building Quality relationships with business partners. The Associate will support the Quality and Regulatory departments in the activities of submissions (Health Canada and formulary), labelling, document control, batch review, product release, complaints, CAPAs and compliance, including Change Control and post-market submission and vigilance activities for the Canadian site.

Reporting Relationships:

\xef\x82\xa7 Quality Assurance and Regulatory Departments
\xef\x82\xa7 Intercompany Affiliates Departments
\xef\x82\xa7 Warehouse Operations and Quality
\xef\x82\xa7 Contract Third Party Business Partners
\xef\x82\xa7 Other company divisions as needed and required by the position

Responsibilities & Duties:

Key Responsibility: Quality Assurance (50%)

The key responsibilities and duties for which the Quality Associate will be responsible include, but are not limited to:

• Drafting, evaluating, and reviewing Annual Product Quality Reports for adverse trends and compliance.
• Tracking stability lots and timepoints and entering stability data into Stability program
• Reviewing batch records, product specifications, Certificates of Compliance, Certificates of Analysis, and all other supporting documentation toward the release of product to the Canadian market.
• Ensuring document control and maintenance of electronic and hard copy GMP records according to company policies and practices
• Assisting in the investigation, review and disposition of product returns, destructions, and recalls.
• Reviewing of compendia for monograph updates and revision to specifications, where necessary.
• Investigating both individually and as a team member, product complaints, adverse events, deviations, and OOS results to determine product impact, root cause and corrective/preventative actions.
• Supporting the change control process of Quality System Records as required to maintain GMP compliance.
• Maintaining and updating Quality Dossiers and records.
• Preparing and reviewing mock labelling for new products and coordinate changes with graphic artist and managing the GS1 database.
• Assisting in the systematic audit of on-site and off-site activities to determine if in compliance.
• Ensuring ongoing compliance with local, national, and international standards and legislation.
• Other duties as required

Key Responsibility: Regulatory Affairs (50%)

• Assist in preparation of pre-market and post-market dossiers for drugs for submission to Health Canada.
• Prepare and review product labels and promotional materials.
• Monitor Health Canada\'s Product Monograph Brand Safety Updates.
• Ensure post-approval regulatory compliance of marketed drug products meeting company\'s and regulatory requirements.
• Prepare and review provincial formulary submissions.
• Other duties as required.

Qualifications:

o BSc in Chemistry, Pharmacy or other Life Science from a Canadian University or a degree recognized as equivalent by a Canadian university or Canadian accreditation body
o Minimum 1 year in a quality or regulatory role working in the pharmaceutical industry.
o Demonstrated knowledge of TPD, ICH Guidelines, GMPs, regulations and other relevant policies
o Strong written and verbal communication skills
o Excellent organization, time management and prioritization skills
o Works well under pressure in a team-based environment
o Meticulous and detail-oriented with strong work ethic
o Sound problem solving and decision-making abilities
o Works independently and accomplishes tasks without supervision
o Proficient user of Microsoft Office products
o Bilingual in French and English is an asset

This description outlines the principal functions of the job identified and should not be considered a detailed description of all requirements that may be inherent in the job.

Location:

Mississauga, CA

Hikma Pharmaceuticals