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

The role is to ensure that all automated systems deployed in Taro Canada 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 Taro Canada;
• 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 Taro Canada 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 at Taro Canada;
• Approve Computer System Registry for presentation to Regulatory Auditors; and
• Other duties as assigned.

Qualifications

• 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 Taro Canada;
• Non- Conformance Investigations; and
• Implement strategies and objectives towards enhancing the quality standards for computerized systems in the department and facility.

Working conditions

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

If you are interested in this opportunity, please submit your resume to [email protected] referencing Compounder in the subject line. We thank all applicants, but only those selected for further consideration will be contacted. No phone calls please.

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.