Senior Quality Assurance Associate, Aurora

Assist Manager, Quality Assurance in the design, implementation and continuous improvement of the company’s quality systems to ensure compliance with current Good Manufacturing Practices (CGMP), regulatory agencies, client and corporate expectations.

JOB RESPONSIBILITIES

Assist in developing and managing company’s quality systems, CGMP compliance and continuous quality improvement projects

Oversee and communicate daily priorities and scheduling of QA activities in coordination with other departments (operations, laboratories, supply chain, etc.)

Review and approve quality related documents, such as equipment (IQ/OQ), process, computerized systems, analytical methods validations, stability protocols and reports, master batch records and executed batch records

Review and approve intermediates, in-process controls and cleaning specifications

Prepare, facilitate and respond to audits (regulatory agencies, client and/or internal)

Ensure the execution and maintenance of company’s quality programs, such as:

Vendor Qualification Program, including the reduced testing program and vendor on-site audits

Internal Audit

Change Control Program

Corrective Actions/Preventive Action (CAPA) system

Trending and tracking of quality systems, such as deviations, investigations, CAPAs, Environmental Monitoring, Municipal water quality results

Ensures that external customer requirements are established and are addressed within the Quality System

Assist QA Manager in conducting major investigations (e.g. product complaints, recalls, returned goods, critical deviations) including review and evaluation of effectiveness of related Corrective Actions/Preventive Actions

Assist QA Manager in hosting regulatory inspections (FDA, HPFBI, PMDA etc) through ensuring pre-inspection preparation, coordinating inspection observation responses, and follow-up

Coordinate and host external client audits through pre-audit preparations, audit observation responses, and follow-up

Execute quality audits in support of external clients and vendor qualifications

Maintain current knowledge in QA, RA, auditing fields and disseminate to other QA staff

Provide CGMP training and refresher training

Act as a designate for Manager, Quality Manager in his/her absence or as required

Perform other duties as assigned

JOB REQUIREMENTS

B.Sc. in Chemistry or related scientific discipline with a minimum of 5 years experience or

M.Sc. in Chemistry or related scientific discipline with a minimum of 2 years experience

Significant experience in a in a Quality Assurance and/or Regulatory Affairs role within the pharmaceutical and/or API manufacturing industry.

Experience in dealing with FDA, HPFBI, TPD and other international regulatory agencies.

Experience in Regulatory Affairs and Analytical chemistry would be an asset.

Proven skills and knowledge in co-ordinating and performing QA/RA activities (e.g. review of GMP documentation, assisting in client and regulatory audits, vendor audits)

Extensive knowledge of FDA, USP and ICH regulations

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