Career Connections Canada Inc.
'Connecting great people with great companies'
Our pharmaceutical client in Brampton is seeking a Senior Associate, QA Computer Systems to join their team.
The role is to ensure that all automated systems deployed in company are compliant to current regulatory expectations related to CFR part 11, GAMP 5 and Data integrity requirements in general.
The role also has oversight of Computerized System Validation (CSV) review and qualification to ensure that those systems are well designed, installed, qualified, and maintained in a state of compliant inspection readiness.
Duties and responsibilities
· Provide QA oversight and input for all enterprise and local computerized systems at company;
· Provides guidance on the risk based validation approach for the computerized system
· Coordinate the creation and development of required validation documents (e.g. URS, FRS, test cases) and provide compliance support to the project team;
· Review and approve validation and computerized system GMP related documents;
· Lead and/or perform investigation and root-cause analyses for any discrepancies/ observations found during computer system validation.
· Lead and coordinate the inspection readiness program to ensure automated system is compliant ready
· Coordinate the required activities related to design, installation, qualification, maintenance of automated systems such as METIS, SAP, LIMS, Trackwise
· Define Periodic Review strategy for new and existing computerized systems and ensure the periodic review is completed on time.
· Provide QA Oversight and guidance in the development and revision of computer system procedures
· Lead internal audits of Computerized Systems when required;
· Participate in Internal, Customer and Regulatory Audits;
· Provide Subject Matter Expert support for Quality Activities (e.g. NCI Investigations, CAPA, Change Controls, Regulatory and Customer Audits);
· Provide oversight for establishing roles, responsibilities and segregation of duties within Computerized Systems utilized;
· Approve Computer System Registry for presentation to Regulatory Auditors;
· Other duties as assigned.
- Bachelor’s Degree in Science, Computer Science or other related discipline;
- Minimum 5-7 year’s experience in a pharmaceutical industry with at least 5 years in Computer system validation (CSV) or Quality oversight for CSV;
- Experience in inspection from Regulatory agencies officials (Health Canada, USFDA, MOH, MHRA…)
- Project management
- Excellent understanding of 21 CFR Part 11 / Annex 11 and GAMP 5 requirements; Good Working knowledge of FDA and Health Canada Good Manufacturing Practice.
- Good written communication and report writing skills.
- Strong influencing skills.
- Strong organizational skills and ability to multi-task; detail oriented.
- Well-developed interpersonal and teamwork skills.
- Ability to work independently with minimal supervision.
- Hands-on knowledge of Microsoft Office applications and computer systems such as ERP, EBR, QMS and LIMS systems.
- Problems associated with a wide variety of computer system quality issues that can be more than routine in nature.
- Problems associated with IT environment and computerized systems.
- Problems associated with dealing with individuals from multiple departments, and working with various functions within and outside the company.
- Non- Conformance Investigations.
- Implement strategies and objectives towards enhancing the quality standards for computerized systems in the department and facility.
- Office environment.
- Ability to work under stressful conditions with aggressive deadlines and changing priorities.
- Numerous and varied responsibilities demanding attention and detail.
***Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Canada Inc.