Senior Associate, Quality (Deviations)

at  Taro Pharmaceuticals INC Canada

Taro Pharmaceuticals Inc. 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
Employee training and organizational development programs, internal mobility programs, and employee recognition programs
Our Brampton location is presently looking for Senior Associate, Quality (Deviations).

QUALIFICATIONS

• Requires Bachelor’s Degree in Science, or related discipline
• A minimum 5 years of experience in a Quality role within the pharmaceutical industry
• Experience with investigations
• Sound knowledge and application of Health Canada and FDA regulations
• Ability to influence others to do things while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals
• Excellent written communication and report writing skills
• Strong organizational skills and ability to multi-task; detail oriented
• Recommends changes and requests investigations where required
• Any deviations to procedures or systems are brought to the Supervisor’s attention with logic, data and corrective measures
• Implement short range strategies and objectives towards enhancing the quality standards of the department and facility

PHYSICAL REQUIREMENTS

Hybrid
We thank all applicants, but only those selected for further consideration will be contacted. This position is open to applicants legally authorized to work in Canada.
Taro Pharmaceuticals Inc. 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 Inc. 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 Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with an agency / recruiter, Taro Pharmaceuticals Inc. 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 Inc. explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency

JOB PURPOSE

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

DUTIES AND RESPONSIBILITIES

• Ensures that all activities related to the recognition, investigation and resolution of non-conformities are performed in a timely manner and in accordance with the company and regulatory requirements
• Investigate deviations (including complex/critical), leads and authors investigation reports
• Review and approval of minor investigations and occasional major investigations with direction and oversight from management
• Oversee execution, review, and approval of investigations, risk assessments and CAPAs with all Taro departments
• Train and coach Lead Investigators on root cause analysis
• Work with Lead Investigators to develop SMART CAPA
• Maintain the investigation & CAPA database(s) with up to date information and progress of each record
• Develop and report metrics
• Work with CAPA task owners to track and ensure timely completion of CAPA tasks
• Write/revise SOPs associated with the area of responsibility as required
• Complete all GMP Documentation correctly and in a timely manner
• Complete all training assignments and maintain personal training records
• Work with other departments to proactively build quality into the processes and systems
• Provide support for client audits and Regulatory Inspections
• Identifies and implements key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements
• Provide support in product recall activities
• Participate in the internal audit program
• Other duties as assigned