Senior Quality Assurance Inspector - BCforward

Quality Operational Specialist supporting manufacturing department quality-related activities. Candidate should have prior GMP inspection and documentation quality review experience within a pharmaceutical manufacturing facility or equivalent. Candidate must be detail-oriented in a fast-paced multi-task environment with good oral and written communication skills and can interact with all levels of management and other supporting departments.

• Conduct audits of Pharmaceutical Development Manufacturing Facility to ensure compliance with CGMP, DEA, Corporate and pharmaceutical development SOPs
• Perform QA Room Releases, line clearances, equipment releases and AQL inspections as required.
• Provide Quality Floor supports during batch manufacturing by performing routine Quality auditing.
• Provide QA support to Manufacturing for clinical and commercial batches
• Audit of executed Batch Records for compliance with CGMP and provide customer audit responses as required
• Audit of raw materials, facility logs, release data.
• Interdepartmental communication for obtaining information and audit corrections
• Comply with and ensure compliance of the department with Health, Safety and Environmental responsibilities
• Assist with batch investigations as required
• Able to work over the weekend and stay outside business hours if required as direct by the department manager.
• Assist other duties assigned by manager to support the department and business.