Senior Associate, Quality Compliance

Job purpose

The main responsibility for this position is to manage on a daily basis, Taro’s CMO activities related to Quality and Compliance. In this position the individual will also support all licensing activities for Taro Canada which includes maintenance of Drug Establishment license and licensable activities for all foreign buildings.

This position will also foster strong relationships with key Pharma customers, Private Label customers, Vendors (raw materials, packaging components, third party logistics and GMP Services) in order to liaise between internal customers and manage all requests to identify, assess and address all quality risk activities and processes according to regulatory guidelines and Taro Standard Operating Procedures. Pls add

Duties and responsibilities

• Foster strong relationships with key Pharma  Vendors
• Ability to provide feedback to Pharma Vendors concerning all quality systems, change control notifications, product environments and laboratory results.
• Foster strong relationships with key internal customers (Research and Development, Regulatory Affairs, Supply Chain, Pharmaceutical Technology)
• Maintain a strong quality presence in the organization to demonstrate a proactive approach to first time quality.
• Prepare and maintain Quality Agreements
• Review and approval of Process Validation and Method Validation reports
• Manage Product Launch Activities
• Respond to customer and vendor queries and notifications within the scope of the quality agreement or Taro SOP’s
• Onboarding of new vendors and the maintenance of approved vendors processing, review and assessment of change controls, specifications, master documents and quality agreements
• Lead and/or Participate in Recall activities
• Lead and/or Participate in Continuous Improvement projects
• Participate in and/or lead Non-Conformance Investigations
• Perform risk assessments (as needed) for material/component/vendor related issues
• Evaluate Vendor performance to determine initial approval and continued status.
• Perform certification of Vendors, materials, components and contract manufacturers.
• Perform audits of Taro Vendors and contract manufacturers (where applicable)
• Support all licensing activities and ongoing communications with Health Canada: liaising with contract manufacturers, laboratories, API sites to obtain required information
• Assist in reporting metrics for Quality Compliance department.
• Maintenance of databases, documents and Approved Vendor Lists (AVLs)
• Ensure compliance to all Taro Quality Management Systems (Training, Corrective and Preventative Actions, Documentation, Change Control)
• Assessment of changes as per Health Canada’s post-NOC requirements
• Prepare, host and participate in Internal, Customer and Regulatory Audits.
• Lead/Train Associates in Compliance related activities.
• Develop and revise SOPs
• 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

• Minimum of B.Sc Chemistry or other associated discipline
• 5 - 7 years experience in quality assurance/quality compliance experience in the pharmaceutical or related industry environment
• Proficient in quality systems such as change control, investigations, documentation, batch review and release.
• Complete knowledge of pharmaceutical operations/standards combined with a strong quality mindset.
• Good organizational skills, detail oriented and multi-tasking ability combined with strong attention to detail
• Excellent written and verbal communication skills with ability to articulate messages and interact with a variety of audiences (internal and external)
• Excellent technical writing skills
• Proven negotiation and training skills in ensuring quality standards are maintained while also meeting business expectations.
• Knowledge of applicable software specifically SAP and Trackwise
• Knowledge of Annual Product review and Product Stability requirements
• Knowledge of Health Canada and USFDA requirements related to Nitrosamine, Elemental Impurity and Residual Solvents
• Knowledgeable of pharmaceutical operations
• Knowledgeable of GMP, FDA and HPFBI requirements
• Ability to manage internal and external requirements
• Strong problem solving skills with ability recommend and implement strategies towards enhancing the quality standards of the department and facility
• Evaluation of customer’s requests without divulging company confidential information

Working conditions

Generally pleasant surroundings working in an office environment.  Fairly level temperatures.  Occasional work in other areas (compounding, warehouse, etc.) as required.

Physical requirements

NA

Direct reports

NA