Job Description

Summary:

The Sr. Quality Specialist will have the primary responsibility of supporting the import and distribution of 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 Sr. Quality Specialist will support the Quality department in the activities of product launch, document control, commercial stability, batch review, product release, complaints, CAPAs and compliance, including SOPs and change control for the Canadian site.

Reporting Relationships:

Core 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 Pharmacovigilance Third Party Provider
\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

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

• Act as an authority to approve the release of Finished Products to the Canadian market.
• Lead the review of batch records, product specifications, Certificates of Compliance, Certificates of Analysis and all other supporting documentation toward the release of product to the Canadian market.
• Support the Commercial Stability Program and ensure monitoring of marketed commercial batches.
• Support the change control process of Quality System Records as required to maintain GMP compliance.
• Act as a project leader on new Product Launches to the Canadian market.
• Coordinate and track any market action or product recalls.
• Assist in complaint handling, complaint investigation, tracking in the internal database, and following up with customers.

• Assist in deviation and incident reporting and investigations internally and with third-parties as required to ensure compliance.
• Support the draft and review Annual Product Quality Reports.
• Maintain and update Quality Dossiers and records.
• Document control: participate in reviews of SOPs and maintenance of electronic and hard copy GMP records according to company policies and practices
• Review of compendia for monograph updates and revision to specifications, where necessary.
• Provide support for maintaining training files for employees to ensure compliance with applicable regulations
• Assist in the systematic audit of on-site and off-site activities to determine if in compliance
• Prepare and review mock labelling for new products and coordinate changes with graphic artist.
• 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 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 5 years in a quality or regulatory role working in the pharmaceutical industry.
o Minimum 3 years\' experience with releasing drug product to the Canadian Market.
o Thorough and 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

Location:

Mississauga, CA

Hikma Pharmaceuticals