Job Description
Lead Operational Quality Advisor - night shift
Job Category: Quality
Requisition Number: CONSE003091
- Posted : May 29, 2024
- Full-Time
- On-site
Locations
Showing 1 location
Description
Work schedule, night shift, Sunday night to Friday Morning, 11pm to 7 am
Would you like to make a difference by putting your talent at the service of human health? A healthier world starts with you! You are the crucial link between our medicines and our patients. Choosing Pharmascience also means choosing yourself, because we place human health, including yours, at the heart of our mission, and your personal and professional achievements are at the forefront of our concerns. Being able to grow means working with a Canadian leader in the generic pharmaceutical industry.
Benefits of working at Pharmascience:
- Annual bonus
- Internal referral program of up to $3,000
- Vacation and floating vacations upon hiring
- Group insurance coverage as of day 1, including telemedicine
- Competitive pension plan with employer contribution as of day 1
- Employee assistance program
- Ongoing training offered
- Stimulating and collaborative work environment
- On-site parking
- Gym
The Lead Advisor QA Operations is responsible for monitoring and maintaining high quality standards at the operational level by assuring the adequate application of Good Manufacturing Practices and internal procedures. He/ She is responsible to monitor KPIs measuring the heath of quality systems such as CAPA's and deviations, active participates in the multi-functional SWAT teams addressing quality incidents. In the case of quality incidents, he/she is responsible for the establishing scope, impact, immediate corrective action and investigation criticality. He/she supports the deviation investigators with identification of scope, impact, immediate corrective action and investigation criticality as needed.
Responsibilities:
Operational Quality Management
- Performs internal audits of the production floor and of the reception/sampling activities.
- Verify the application of GMPs, Health & Safety and internal procedures, makes recommendations and manages cases of non-conformity with the responsible personnel involved.
- In cases of non-conformity, participates in determination of immediate action requirements, including lot or partial lot inspections, and lot disposition. Coordinates/ performs inspections.
- Documents actions and lot disposition information electronically in Trackwise and SAP.
- In cases of production non-conformity, actively participates in SWAT discussions and facilitates engagement by cross function team. Represents Quality in the SWAT discussions and ensures correct actions are performed from a quality and compliance point of view.
- Supports investigators of non-conformances and support implementation of effective CAPAs as required Categorizes the quality events and assures immediate actions are identified/adequate and performed.
- Support of audits (client, regulatory, internal) as required.
- Provide guidance and coach, Operational Quality Advisors as well as Operations and QA Investigators.
- Support management of workload related to LIR, Deviation and CAPA systems.
- Monitor, report and ensure the respect of KPIs for Deviation and CAPA systems.
- Review and approve LIR, Deviation, CAPA, INF / FOR / WI documentation.
Documentation
- Approve documents related to rework, inspection requests and AQL.
- Prepare samples and submit them to QC laboratories. Enter samples with unique identifier and generate the Certificate of Analysis in LIMS.
- He/ She conducts review and approval of LIRs, minor/ major deviation reports and INF/FOR.
QA support to business
- Actively participate in problem solving and continuous improvement initiatives.
- Prepare and/or participate in training activities.
- Maintain Operational Quality Advisor team tools and files.
- Monitors and ensures respect of departmental KPIs and objectives.
- Supports risk analysis and trending activities to ensure long-term compliance of operational activities with GMP
Skills, Knowledge and Abilities:
- Capacity to take decisions and to communicate them with tact and diplomacy
- Proven coaching and leadership skills
- Analytical skills
- Thoroughness and Rigor
- Solid organizational skills
- Technical writing skills
- Ability to communicate in French (oral & written)
- Competent with MS Office, SAP, LIMS
Qualifications
Skills
Required
Fluent in French oral and written
Advanced
Education
Required
Bachelor or better in Science or related field.