Job Purpose The main responsibility for this position is to manage all compliance programs associated with Contract Manufactured products as per Health Canada and US FDA regulations. Senior Associate, QA (CMO Compliance) role is also accountable for assessment of the new and potential Contract Manufacturing Organizations and 3PL facilities with potential distribution in Canada with the target to evaluate their compliance status and associated business risks.

Senior Associate, QA (CMO Compliance) will write, execute and maintain Sun Pharma Canada Inc. Quality Assurance Agreements with CMO and 3PL and audit these organizations accordingly.

This position is also responsible for routine batch release activities of CMO batches for Canada market and all associated responsibilities targeted to manage all requests to identify, assess and address all quality risk activities and processes according to regulatory guidelines and Sun Pharma Canada Inc. Global Quality Standards.

Duties And Responsibilities

• Plan, execute and track the following CMO associated Compliance Programs:

• Full Batch Review Program

• Unique Identifier Program

• Freeze-Thaw Studies

• Annual Testing Program

• Transportation Studies

• Product Launch documentation

• Create Performance metrics of CMOs and provide status reports on the above Programs to the leadership

• Perform compliance assessment of the new CMOs, CDMO, Contract Labs, Contract Packagers and 3PL operations; create an effective preliminary and detailed compliance screening process

• Lead all activities associated with introduction of the new CMO and CDMO, review and approve all associated documentation

• Perform initial GMP and routine on-site and remote audits and checks for all CMO, CDMO, Contract Labs, Contract Packagers and 3PL operations for the products marketed in Canada and USA

• Follow up on the responses from the auditees and ensure CAPAs effectiveness checks execution

• Provide feedback to CMOs concerning documentation management, all quality systems, change control notifications, investigations and laboratory results

• Create, finalize to approval status and maintain periodical review of all Quality Assurance Agreements for CMOs, Contract Labs and Contract Packagers for the products marketed in Canada and USA

• Ensure compliance to responsibilities outlined in executed Quality Agreements

• Foster strong relationships with key internal customers (Research and Development, Regulatory Affairs, Materials Management, Pharmaceutical Technology)

• Perform risk assessments (as needed) for CMOs and its products, where required

• Ensure Health Canada licensing requirements are met prior to introduction of a new CMOs, Contract Labs and Contract Packagers or a new product

• Assist in site regulatory/ customer inspections

• Ensure compliance to all Sun Pharma Canada Inc. Quality Management Systems (Training, Corrective and Preventative Actions, Documentation, Change Control)

• Respond to customer queries for the CMO products

• Evaluate the Contract manufacturer, Labs and Packagers on a routine basis for compliance as per Health Canada requirements

• Perform investigations with respect to the contract manufactured products, where required

• Maintain a strong quality presence in the organization to demonstrate a proactive approach to first time quality

• Perform day-to-day CMO market release activities including review/approval of associated Investigations and Change Controls records. As well as track and monitor the batch release activities

• Support Canadian market recalls for Sun Pharma Canada Inc. products manufactured by CMO and Sun Pharma sites

• Lead and/or Participate in Continuous Improvement projects

• Lead/Train Associates in Compliance related activities

• Develop and revise SOPs

• Other duties as assigned

Additional Responsibility 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 (creams, gels and ointments)
• 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, example, SAP, Trackwise etc.
• 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.
• Approximately 20 - 25 % of travel, mainly within North America, will be required.

Physical Requirements 5 days on-site role