Associate II, Commissioning, Qualification and Validation (CQV) chez OmniaBio
OmniaBio · Hamilton, Canada · Onsite
- Professional
- Bureau à Hamilton
Position Summary
The Associate II, Commissioning, Qualification and Validation, supports activities including development of validation master plan(s), and qualification/validation of deliverable(s) and standard operating procedures (SOPs). Responsibilities include assessment and development of qualification documentation for the facility, equipment, and systems, and ensuring the documentation and equipment is compliant for manufacture to Good Manufacturing Practices (GMP) standards.
Responsibilities:
- Validates master plan and deliverable development, including equipment, facilities, utilities, computerized systems and processes, installation qualification, operational qualification, and performance qualification. Ensures these documents meet the minimum regulatory requirements at an appropriate level of validation.
- Collaborates with key stakeholders and user groups, including Manufacturing Science and Technology, Process Development, Operations, Information Technology and Quality Assurance, as well as clients to accurately develop documentation requirements. documentation requirements.
- Prepares, revises and updates validation activities schedule.
- Reviews qualification-related documentation.
- Completes qualification documentation periodic review.
- Develops SOPs, preventive maintenance and calibration programs.
- Prepares temperature mapping protocols and summary documents.
- Contributes to alarm rationalization assessments and management of required alarm documentation.
- Completes deviations, change control, impact assessments, corrective and preventive actions and other associated records.
- Participates or leads risk assessments and mitigation strategies, as required.
- Completes periodic review of commissioning, qualification and validation (CQV) documentation/SOPs.
- Participates in customer and internal audits as a subject matter expert.
- Meets all deadlines associated with projects as directed, including all reports and documentation.
- Keeps the Manager/Supervisor, Commissioning, Qualification and Validation, updated on all schedules, qualification testing results, and all other departmental activities.
- All other duties, as assigned.
Requirements:
- 3+ years of experience in a related CQV position in a biopharma/pharmaceutical GMP environment.
- Postsecondary education in engineering technology or similar qualification preferred.
- Strong English written and oral communication skills.
- Previous experience participating with audit inspections.
- Experience with qualification HVAC systems and Grade A, B, C and D clean rooms.
- Knowledge of regulatory guidance for related aseptic, cell and gene therapy and regenerative medicine (e.g., Health Canada, U.S. FDA, EMA, ICHQ7, GAMP5, 21 CFR Part 11, ISPE, EU Annex, USP <1079.)
- Knowledge of qualification of manufacturing automated systems/PLC systems.
- Strong technical writing skills.
Desired Competencies and Behaviours:
- Independent, detail-oriented, self-starter with excellent analytical skills, able to multitask and succeed in a team environment.
- Strong communication skills and able to work with internal and external partners.
- Possesses integrity.
- Demonstrates resilience and tenacity.
- Diligent.
- Works well with a team.
- Possesses interpersonal awareness.
- Has a high level of energy to persevere through challenging and demanding situations.
