Title:  Associate, Quality Assurance, IT and CSV

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.

Our reward packages have been designed to meet the needs of our diverse workforce and their families. For additional information visit: www.taro.com.

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.

Duties and 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;
  • Risk Assessment and Validation Matrix for new and existing computer systems subject to validation;
  • 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 cross-functional teams;
• Create a positive and effective attitude towards CSV and regulatory compliance;
• Train staff; ensure training effectiveness;
• Participate and/or leads meetings with IT and business user representatives in order to gain cross functional understanding and consensus on protocol content and protocol execution; and
• Maintains up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer operations, and acts as an information resource for the team and wider business.

Qualifications

• Bachelor’s Degree in Science, Computer Science or other related discipline;
• Minimum  3-5 years’ experience in a pharmaceutical industry with at least 3 years in Computer system validation (CSV) or Quality oversight for CSV;
• Excellent understanding of 21 CFR Part 11 / Annex 11 and GAMP 5 requirements; Good Working knowledge of FDA and Health Canada Good Manufacturing Practice;
• Experience in inspection from Regulatory agencies officials (Health Canada, USFDA, MOH, MHRA etc.);
• Good written communication and report writing skills;
• Strong influencing skills;
• Strong organizational skills and ability to multi-task; detail oriented;
• Well-developed interpersonal, communication, 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; and
• Ability to resolve problems associated with a wide variety of computer system quality issues that can be more than routine in nature.

Working Conditions

• Office environment;
• Ability to work with aggressive deadlines and changing priorities; and
• Numerous and varied responsibilities demanding attention and detail.

This position is open to applicants legally authorized to work in Canada.

Taro Pharmaceuticals embraces diversity in the workplace and is committed to achieving employment equity. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We ensure that our recruitment practices are supportive of this commitment and do not infringe on any characteristics protected by law.

In accordance with the Accessibility for Ontarians with Disabilities Act, 2005, and the Ontario Human Rights Code, Taro Pharmaceuticals will provide accommodation throughout the recruitment and selection process to applicants with disabilities. If selected to participate in the recruitment and selection process, please inform Human Resources of the nature of accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation.

NOTE: All employment is conditional upon the completing and obtaining of a satisfactory background check which may include educational, employment, references and criminal records (for which a pardon has not been granted) checks.

AGENCY NOTICE: Please note that Taro Pharmaceuticals does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with an agency / recruiter, Taro Pharmaceuticals will not consider any referrals or agree to payment of referral or recruitment fees. In the event a recruiter or an agency submits a resume or candidate without a previously signed agreement, Taro Pharmaceuticals explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.