Title:  Associate, Quality Assurance (Product Release & Logistics)

Job purpose

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 Sun Pharma Canada manufacturing site.

This position acts as an active influence towards elevating the quality practices and guidelines for products manufactured, packaged or tested at the Sun Pharma 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 (Sun Pharma and 3rd Party) based on the comprehensive review process.

Duties and responsibilities

• Perform timely evaluation and make decisions on disposition of the finished products /Raw materials ( API and Excipients) /components 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 disposition  (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, LIMS, 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.

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

• B.Sc. degree in Chemistry, Biochemistry, Pharmaceutical Science, or a related field is required.
• Minimum of 3 years of experience in a Quality role within the pharmaceutical or related industry, specifically involving product release, raw material release, and pharmaceutical operations/manufacturing is required. Experience at the QA level within these areas is preferred.
• Sound knowledge and understanding of Health Canada and FDA regulations
• Experience and/or knowledge of Pharmaceutical manufacturing and packaging is an asset
• Experience with SAP and Trackwise is required
• Skilled Word and Excel user
• Good written and verbal communication skills
• Ability to influence others while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals
• Strong organizational skills and ability to multi-task; attention to detail
• Strong troubleshooting and problem solving abilities
• Change leader and driver
• High energy level, self-starter
• People skills, ability to influence others

Working conditions

• Ability to work under stressful conditions and prioritize workload
• Numerous and varied responsibilities demanding attention and detail
• Stress tasks and environment during regulatory and customer’s inspections
• Regular presence on manufacturing/packaging shop floor in collaboration with Operation’s staff
• Rotating shifts

Physical requirements

NA

Direct reports

N/A

Job Posting Description

This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $70,000 to $87,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; RRSP savings plan; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, ethnic origin, citizenship, ancestry, sex, age, marital status, family status, physical or mental disability, gender identity, gender expression or any other ground protected by applicable human rights legislation.

The Company does not use artificial intelligence to screen, assess or select applicants.

Notice to Agency and Search Firm Representatives:   Sun Pharmaceuticals Industries, Inc. (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.  Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun.  No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.