QA Inspector

2 days ago

Brampton, Canada Taro Pharmaceuticals INC, Canada Full time

**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.

**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 main responsibility of this position is to perform regular QA inspection checks during the day to day packaging and compounding operations at Taro Canada. This activity would include routine line inspections for GMP requirements, bulk and documentation to ensure first time quality is built into the finished product to meet Taro and government agency cGMP requirements.

**Principal Duties and Responsibilities**:

- Perform routine line clearances/inspections on the packaging lines.
- Provide Line clearance certification and re-certification to production floor
- Ensure routine compliance of day to day activities on the compounding and packaging areas; working with operations personnel to achieve compliance.
- Monitor packaging and compounding to ensure that batch documentation requirements and SOPs are being followed.
- Review the required paperwork for accuracy and compliance on line and upon completion of the activity.
- Initiate incident reports and perform initial floor investigations and impact assessments to ascertain product quality impact as required.
- Coordinate and cooperate with investigation team to complete investigations in timely manner.
- Collect representative samples for testing and retention, and ensure all relevant paperwork is complete. Submit samples/re-samples to laboratory in a timely fashion to meet business needs.
- Maintain sample and retention records program.
- Communicating discrepancies to QA Manager / QA Supervisor or other departments where required.
- Work effectively with operation personnel to build in quality up front in the process.
- Prepare and update written procedures (SOPs/Forms/WIs) in areas of responsibility.
- Automate job functions to achieve continuous increase in productivity.
- Issuance, monitoring, review and archival of Production Log book review,
- Perform Real time review of PWOs and related documents (paper documents as well as /electronically)
- Perform QA review for Magnehelic gauges, Pest control and Temperature monitoring in the GMP areas and prepare quarterly EM reports
- Perform routine inspection of GMP areas and provide coaching to improve compliance and GMP behaviour
- Provide continuous support to packaging line, assess issues in GMP manner and provide real time solutions
- Initiate change control as required
- Initiate incident reports related to production areas, as required
- Provide floor support to investigation team and perform QA review of event reports, as required
- Oversee temperature monitoring systems for GMP areas; TempTale procurement, configuration, installation and monthly data downloading and trending.
- Initiate Product hold / Reject notification requests
- Record GMP observations on production floors on shift basis and communicate as required
- Update databases as required related to Quality Operations.
- Review and approve exceptions in electronic batch system.
- Provide one on one coaching to packaging support staff i.e. mechanics to improve RFT and good documentation practices
- Share GMP ideas/ thoughts and provide feedback to production floor during kick off meeting/weekly/monthly meetings
- Other duties as assigned

**Knowledge, Skills and Abilities**:

- Thorough GMP and SOP knowledge
- Knowledge of pharmaceutical manufacturing processes and chemicals
- Excellent written and verbal communication skills to communicate effectively to key areas/departments
- Ability to

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