Associate, QA

3 weeks ago

Brampton, Canada Taro Pharmaceuticals INC, Canada Full time

**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.

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

Our Brampton location is presently looking for **Associate QA (Contract)**

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 (CAPA’s) 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. Deg

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