Associate, Quality Assurance, IT and Csv

3 weeks ago


Brampton, Canada TARO PHARMACEUTICALS INC. Full time

Taro Pharmaceuticals is a multinational, specialty pharmaceutical company with a vision of reaching people and touching lives globally as a leading provider of valued medicines. We are dedicated to meeting the needs of our customers and the overall community through the innovation, development, manufacturing and marketing of the highest quality healthcare products.

Established in 1950, Taro’s world class production facility is located in Brampton, Ontario, with a current team of over 600 Canadian employees. Our company’s focus on the dermatology sector has made us a leading manufacturer and supplier of specialized topical products with a diverse portfolio of creams, ointments, liquids, and gels.

With support from our parent company, Sun Pharma, one of the world’s largest specialty generic pharmaceutical companies, we are committed to providing a healthy, safe and rewarding environment for all of our employees.

Taro Pharmaceuticals is a multinational, specialty pharmaceutical company with a vision of reaching people and touching lives globally as a leading provider of valued medicines. We are dedicated to meeting the needs of our customers and the overall community through the innovation, development, manufacturing and marketing of the highest quality healthcare products.

Established in 1950, Taro’s world class production facility is located in Brampton, Ontario, with a current team of over 600 Canadian employees. Our company’s focus on the dermatology sector has made us a leading manufacturer and supplier of specialized topical products with a diverse portfolio of creams, ointments, liquids, and gels.

With support from our parent company, Sun Pharma, one of the world’s largest specialty generic pharmaceutical companies, we are committed to providing a healthy, safe and rewarding environment for all of our employees.

**What we offer**:
A safe and clean; GMP regulated work environment
Opportunities for career growth and development
A competitive wage/salary
Incentive bonus programs that are designed to reward employees for their individual contributions
Benefit programs designed to support our employees and their families, including a comprehensive health & dental benefits package, group RRSP matching program, direct access to healthcare and well-being programs, and paid time off
Employee training and organizational development programs including tuition reimbursement, internal mobility programs, and employee recognition programs

Job Purpose
This role is responsible for assisting Quality Assurance oversight of all aspects of the validation of computerized systems at the facility. Guide business in Validation of computerized system effectively, provide direction, resolve validation issues and ensure proper documentation. Act as a compliance resource by collaboratively interacting with all departments to create a positive and effective attitude towards computerized system validation and compliance. This position will entail coordination with other departments within the organization, including R&D.

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.

**Responsibilities**:
Responsible to ensure all aspects of the validation of computerized systems are in compliance with Taro SOPs, CSVMP, FDA 21 CFR Part 11, GAMP, EU Annex 11 and applicable regulatory requirements (including contractors, consultants, and technicians that will participate in computer validation activities);
Define risk based validation strategies for computerized systems and network infrastructure;
Assist in QA harmonization of the computer validation approach across the organization;
Coordinates and guide in the development of validation documents and perform review of:
Change controls for computerized system implementations, maintain change control log and follow up with owners on the timely closure of change control files closure;
Validation master plans for computerized system implementations;
SOPs for computerized system implementations, where required;
Qualification scripts, deviations reports or logs. Ensures assignable causes are identified and address corrective actions, as needed; and
Vendor approvals for computerized systems including audit review and approvals.
Support Taro Data Governance Program to establish, control, monitor and record all activities that directly or indirectly impact all aspects of the quality of drug products;
Develop (with manager’s support), maintain, monitor, and ensure effectiveness of computerized system validation program for GxP computerized systems;
Participate and present CSV validations in audits;
Author CSV and applicable Standard Operating Procedures (SOPs). Review, perform gap analysis and provide feedback on corporate guidelines and regulation;
Act as a compliance resource by collaboratively interacting with c



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