Operations Quality System Senior Specialist

Operations Quality System Senior Specialist Who We Are At CPL, we are passionate about pharmaceutical product development and contract manufacturing. Our aim is to be the top choice CDMO in the non‑sterile liquid and semi‑solid pharmaceutical products domain, and ultimately bring benefits to the customers using our manufactured products. For more than 30 years CPL has partnered with the world’s leading pharmaceutical companies to provide full‑service product development and manufacturing, singularly focused on innovation and efficiency. We recognize our employees are our number one asset and support their career growth. Job Summary Assist site management to maintain the overall health and compliance of the Operations Quality System. Lead investigations for non‑conformances in accordance with regulatory requirements and company procedures. Collaborate cross‑functionally in support of identification of root cause for each assigned investigation, obtain alignment on Correction Action(s) and Preventive Action(s) (CAPAs) that address root cause, and define appropriate Effectiveness Checks (ECs) to prevent recurrence. Initiate and implement the requirements of CAPAs, Change Controls (CCs), and ECs, to ensure accurate and on‑time closure. Participate in audits and inspections as a Subject Matter Expert (SME) for investigations; and write responses as required. Develop and deliver training content and programs based on current and anticipated training needs. Job Responsibilities Lead all activities related to identification, communication, and root cause analysis of non‑conformance investigations in operations. Ensure quick resolution, where possible immediate correction, of non‑conformances associated with a wide variety of quality issues that could range from processing errors, incomplete work orders, out‑of‑range setup/operating parameters, component reconciliation, substandard documentation practices, etc. Apply root cause analysis tools to ensure a thorough investigation and identification of root cause, along with contributing factors. Ensure on‑time closure of all assigned Quality Systems Records (i.e., Investigations, CAPAs, CCs, ECs). Collaborate cross‑functionally in support of accurate root cause identification, creation of robust CAPAs, and creation of appropriate ECs. Propose and assign CAPAs to correct the issue and prevent recurrence, and ECs to ensure sustained effectiveness is demonstrated. Attend customer meetings as investigations SME as required. Support Regulatory Inspections, Customer Audits, and Internal Audits as investigations SME. Drive continuous improvement of investigations, adoption of standard methodologies, and ensure integrity of the system with regulatory, customer, and site requirements. Collaborate with area leadership to identify skills or knowledge gaps and make recommendations for enhanced compliance, training and future improvements. Seek to improve and simplify site processes and procedures, specifically relating to the Operations function to ensure compliance is always maintained. Develop training content and conduct training on new or revised SOPs or Work Orders, as well as on‑the‑job training content in operations. Initiate and lead change controls implementation plans, leading/participating in cross‑functional team risk assessment and providing guidance in change management process. Other duties as assigned. Education Bachelor of Science (BSc) in a Scientific or Engineering discipline. Experience A minimum of 5 years of experience in the pharmaceutical industry. Knowledge, Skills, Abilities Strong working knowledge of current Good Manufacturing Practices and Health Canada, FDA and EMEA regulatory requirements. Good knowledge of pharmaceutical processes (manufacturing, packaging, equipment, facilities), quality concepts and regulations is desirable. Previous training experience in the pharmaceutical industry (an asset). Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization. Solid presentation and facilitation skills, preferably in a training environment is required. Flexible, ability to prioritize, meet deadlines, and capability to engage others. Strong computer skills, with the ability to generate spreadsheets, reports and presentations. Working knowledge of TrackWise is an asset. Being available on off hours for consultation with team to provide assistance as required to minimize downtime. Embodies CPL's values of Excellence, Ownership, Integrity, Agility, Rigor. Willing to work irregular hours, weekends, when necessary. Physical Demands / Working Conditions Regular office environment with significant exposure to plant operations environment. Need to interact and work with staff in multiple shifts (Day, Afternoon and Midnight shifts). CPL is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. CPL is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us. We thank all applicants for their expression of interest; however, only those selected for an interview will be contacted. No phone calls or agencies please. #J-18808-Ljbffr