Job purpose

The main responsibility for this position is to provide compliance support to meet Sun and Regulatory requirements and ensure that all activities related to investigations and complaints are completed thoroughly and in a timely manner.

Duties and responsibilities

• Accountable to ensures that all activities related to the recognition, investigation and resolution of non-conformities are performed on a timely manner and in compliance with company and regulatory requirements.
• Leads and writes Deviations/Non-Conformances investigation reports
• Facilitate meetings with multiple Subject Matter Experts (SME's) as required.
• Perform thorough impact analysis in collaboration with all SMEs including Vendors.
• Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations.
• Regularly review on-going progress on all open investigations with Production Investigations team, QA approver team and Production Management team to ensure all timelines are attainable.
• Escalate any roadblock/issues which may pose the risk for meeting the investigation timelines.
• Prepare clear, accurate and concise investigation reports and review the reports for completeness and accuracy prior to approval by Department Manager
• Works closely with Production Managers and Release Teams to ensure investigations are closed within timely manner.
• Supports the CAPA and Customer Complaints programs as requested by Manager.
• Identifies and trends recurring Deviations /Non-Conformances and ensures appropriate actions are taken such as Management and Regulatory Notifications
• Creates training related to CAPA, Root Cause Analysis and production investigations to Sun employees' personnel as required.
• Develops or assists with Change Controls and SOP's as required.
• Participates in the internal audit program.
• Other duties as assigned.

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• B.Sc. degree in a Chemistry/Chemical Engineering stream or related STEM discipline.
• Three (3) years of experience conducting investigations and writing Deviation Reports, Complaints, CAPAs, and Change Control in a Pharmaceutical or GMP industry.
• Detailed knowledge of cGMP, GLP, FDA and Health Canada guidance and Regulations
• Knowledge of Manufacturing and packaging processes is an asset
• Strong research and problem-solving skills, with the ability to effectively perform analysis
• Strong interpersonal skills to facilitate effective interaction with co-workers and other departments.
• Strong written and verbal communication skills are required in order to communicate effectively with key areas/departments.
• Excellent technical report writing skills.
• Ability to work in a fast paced environment and prioritize workload accordingly in conjunction with the Production Management
• Proficiency with applicable software (TrackWise, MES Document Management System, and Microsoft Office)

Working conditions

• General conditions include office and warehouse work; mix of standing, walking, and desk work
• Clean environment
• Overtime as required or may need to periodically adjust working hours to meet with shift employees

Physical requirements

Office based

Direct reports

NA

This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $73,500 to $92,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; RRSP savings plan; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).