Job Description

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 Sun 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.
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)
• Review MFs (paper / MES), release bulk to packaging, enter and verify CPPs data as applicable
• 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 behavior
• 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.

Additional responsibility (Only applicable to customer facing roles)

• Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• Requires Bachelor's Degree in Science, or equivalent
• Minimum 1-3 years QA/QC experience in pharmaceutical industry, preferred QA experience within the production/manufacturing environments
• 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 multi-task with strong organizational skills to organize daily events to meet departmental and Taro business commitments
• Ability to work in a fast-paced environment and prioritize work accordingly.
• Strong interpersonal skills to interact with production line staff and management staff
• Training in WHMIS
• Strong computer skills are an asset
• Any deviations to procedures or systems are brought to the manager's attention with logic, data and possible corrective measures
• Analyze situations and make decisions that may impact on production efficiencies and quality requirements
• Effectively communicate deviations and corrective actions to manager to establish continuous improvement practices

Working conditions

• Clean environment with occasional exposure to higher than normal noise levels.
• Regular exposure to moving equipment
• Exposure to wide variety of bulk products, raw materials and chemicals on a daily basis.
• Continuous walking and standing with lifting involved
• Occasional overtime and vacation coverage

Physical requirements
Office based.
Direct reports
NA