Associate, Quality Assurance in 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, Taros world class production facility is located in Brampton, Ontario, with a current team of over 600 Canadian employees. Our companys 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 worlds 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 forAssociate, Quality Assurance.

Job purpose

This position is responsible for the maintenance of the quality assurance and release systems to meet Canadian GMP and FDA regulations, to ensure regulatory requirements are achieved and to provide quality oversight to the Taro manufacturing site.

This position acts as an active influence towards elevating the quality practices and guidelines for products manufactured, packaged or tested at the Taro Canada manufacturing facility.

The incumbent holds responsibility over timely decisions on disposition of materials/components for use in production and market disposition decisions for finished products (Taro and 3rd Party) based on the comprehensive review process.

Duties and responsibilities

• Perform timely evaluation and make decisions on disposition of the finished product/material/component based on the review of all required documentation ensuring accuracy and compliance with the established Standard Operating Procedures and regulations.

• Update inventory management systems with appropriate lot status designation (reject, hold, quarantine and approved).

• Determine status disposition for returned goods, complete all necessary documentation and enter this information into the dedicated electronic system.

• Complete department metrics and reports; communicate with key personnel on the release timeframes.

• Complete customer requests ensuring execution of the appropriate paperwork; send the samples to the customers in a timely manner.

• Perform activities as an active user of electronic systems such as SAP, TrackWise, MES, DocuSign etc.

• Participate and provide quality input in review and revision of Quality Assurance, Production, Compounding, Packaging and other applicable procedures (SOPs).

• Ensure compliance to SOPs & GMP requirements in regard to shop-floor activities, Retain Sample Program, water sampling, balance calibration, etc.

• Participate in design of training materials and deliver training targeted to ensure understanding of compliance requirements to Quality Assurance, Production, Compounding and Packaging personnel.

• Consistently work with other departments to proactively build quality into the processes and systems.

• Identify and implement key process improvements targeted to enhance systems, gain site efficiencies, reduce cost of goods and elevate the site level of compliance.

• Participate in and/or lead non-conformance investigations; work with other GMP controlled departments to address quality issues associated with compounding, production and/or packaging stages of the product manufacturing.

• Participate in GEMBA walks and consult shop-floor personnel on the requirements of the batch records execution.

• Issue necessary forms and documentation to the shop-floor personnel.

• Participate in the Product Recall activities as required.

• Ensure that Good Documentation Practices are followed by Production, Packaging and Compounding personnel; influence Right First Time approach.

• Complete Corrective and Preventive Actions (CAPAs) within established timeframe.

• Initiate, and follow through with actions required to close Change Control Records on time.

• Participate in Internal and Customer Audits and Regulatory inspections.

• Complete all training assignments and maintain personal training records.

• Other duties as assigned.

Qualifications

• B.Sc. Degree in Chemistry, Biochemistry, Pharmaceutical Science or related field

• Minimum 3 years of experience in a Quality role within the pharmaceutical or related industry

• Sound knowledge and understanding of Health Canada and FDA regulations

• Experience and/or knowledge of Pharmaceutical manufacturing and packaging is an asset

• Experience with SAP and Trackwise is an asset

• Skilled Word and Excel user

• Good written and verbal communication skills

• Ability to influence others while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals

• Strong organizational skills and ability to multi-task; attention to detail

• Strong troubleshooting and problem solving abilities

• Change leader and driver

• High energy level, self-starter

• People skills, ability to influence others

Working conditions

• Ability to work under stressful conditions and prioritize workload

• Numerous and varied responsibilities demanding attention and detail

• Stress tasks and environment during regulatory and customers inspections

• Regular presence on manufacturing/packaging shop floor in collaboration with Operations staff

• Rotating shifts

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.

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.