26 Oct
|
Mantu
|
Quebec City
Amaris Consulting is looking for a Decommissioning Lead to manage the retirement of oral solid dose manufacturing equipment at a Canadian pharmaceutical contract-manufacturing site.
The facility is transitioning away from solid dose production to focus on aseptic liquid filling. The cleared area will be rebuilt to support additional filling capacity.
This role includes two phases:
Process remediation.
Decommissioning execution.
Key responsibilities
Phase 1: Process remediation
Review and strengthen the existing decommissioning framework, including:
Validation Master Plan
SOPs
Change-control procedures
Identify gaps against Health Canada and FDA GMP expectations.
Write or revise the decommissioning SOP and supporting templates.
Develop:
Isolation and disconnection checklists
Cleaning and decontamination-verification documents
Define a risk-based approach by equipment category, product contact, potency, and system complexity.
Build the decommissioning master plan, including:
Asset inventory
Resources
Milestones Schedule
Present the revised process to QA and Validation for review and approval.
Phase 2: Decommissioning execution
Lead the decommissioning of oral solid dose manufacturing equipment, potentially including:
Dispensing booths
High-shear and fluid-bed granulators
Dryers
Mills
Tablet presses
Encapsulators
Primary packaging lines
Dust-collection and containment systems
Raise and manage asset-specific change controls.
Retire associated calibration, preventive-maintenance, and requalification plans in SAP, CMMS, or similar systems.
Oversee cleaning, decontamination, and verification of product-contact equipment.
Coordinate the retirement of computerized systems, including PLC, HMI, SCADA, and standalone data systems.
Ensure data archiving, records retention, and audit-trail preservation in accordance with data-integrity requirements.
Coordinate with Engineering, Maintenance, EHS, Facilities, and contractors on:
Lockout/tagout
Utility disconnection
Electrical systems
Compressed air
Dust extraction
Physical equipment removal
Document the final disposition of each asset, including
📌 Decommissioning lead (Quebec City)
🏢 Mantu
📍 Quebec City