Quality Assurance Manager
7 days ago
**PSYGEN LABS INC.**
Designation**:QA Manager (Maternity Leave Coverage)**
**Key Responsibilities**:
- Manage the overall site Quality Systems that encompass compliance to Regulatory GMPs and guidance governing manufacturing production, analytical testing, and all supporting functions and activities at the site.
- Manage, in collaboration with all stakeholders, the batch production readiness process. Anticipate and resolve issues to attain on time batch start deadlines.
- Participate in weekly meetings with Operations staff and provide weekly progress reports to facility management.
- Manage the Deviation program process that ensures thorough and timely investigations are completed to correctly identify root cause and develop and implement robust and comprehensive CAPA.
- Administer appropriate escalation of critical events to the Director of Quality and Compliance and ensure close communication with clients on quality issues potentially impacting product quality.
- Manage and oversee the batch record review and batch disposition process to ensure thoroughness and completeness of quality review whilst directing and coordinating the requirements and deliverables to achieve target batch disposition timings.
- Review and approve CAPA for deviations, OOSs, NCRs as required including CAPA Effectiveness Checks.
- Review and approve Validation and Qualification protocols and reports including analytical method transfers and validation.
- Oversee and manage change control program; review and provide input to change controls.
- Oversee supplier qualification program and vendor change notification process. Review and approve vendor and supplier audit reports where required.
- Review and approve SOPs for Quality Assurance, Quality Control, Manufacturing, and Facilities as required.
- Support client audits and oversee and approve client audit observation responses and audit close out reports.
- Co-chair Health Canada audits and collaborate with personnel to support all compliance requirements.
- Oversee preparation and approve annual product quality reviews prepared for client products.
- Develop, implement, and oversee Site Quality Risk Management Program including facilitation of training and education on Quality Management System and cGMP.
- Stay current with regulatory and industry standards and guidance and establish a process to communicate and educate site personnel.
- Would be responsible for implementation of e-QMS on site post closure of the validation batches for Psygen along with the entire QA team.
- Actively share knowledge and experience within the organization and provide input to corporate procedures and guidance on establishment and improvements in Psygen’s Quality Management System.
**Qualifications and Experience**:
- Bachelor’s degree in chemistry, pharmaceutical sciences, or related field.
- Minimum of 3 years’ experience as a Quality Manager or related progressive experience in a Quality leadership role.
- Demonstrated ability to lead the development of quality system processes and documents, including actively advocating for quality interests across departments.
- Effective communication skills, including comprehension, verbal, listening, and written.
- Strong analytical skills for assessing and improving complex processes.
- Proficiency in MS Office 365, Outlook, and Sharepoint.
- Knowledge of Quality Assurance related software including e-QMS, ELN, LIMS, ERP.
- Familiar with cGMP, FDA, and Health Canada Regulations, as well as USP and ICH guidelines.
- Understand the concepts and principles of Quality by Design to integrate quality requirements in a seamless fashion.
- Experience in conducting and/or hosting quality inspections/audits.
- Capacity to assess scientific and technological data from a quality perspective.
- Flexibility to adapt easily to change in the workplace and changing priorities.
**Salary**: $80,000.00-$100,000.00 per year
**Benefits**:
- Casual dress
- Dental care
- Extended health care
- Life insurance
- Paid time off
- Stock options
- Vision care
- Wellness program
Flexible Language Requirement:
- French not required
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Calgary, AB T2A 7X1: reliably commute or plan to relocate before starting work (required)
**Education**:
- Bachelor's Degree (preferred)
**Experience**:
- Quality management: 5 years (required)
- cGMP Manufacturing: 2 years (preferred)
Work Location: In person
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