Job Overview:
The Quality Assurance Professional provides direct support to a production area as part of an Integrated Product Team. The role ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing Practices, and represents quality on the shop floor.
This position performs review of process documentation/data for accuracy, completeness, and data integrity compliance. They may support the completion of batch disposition activities for release of product and assist in conducting investigations of deviations.
In addition, the Quality Assurance Professional spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right first time, and to ensure compliance with cGMPs and regulatory requirements.
Responsibilities:
* Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
* Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures
* Provides presence on the shop floor to support compliance and data integrity
* Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
* Actively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution
* QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment
* Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation
* Participates as the quality member on cross-functional projects
* Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
* Provides support to internal audits and regulatory inspections
* Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans
* Drive continuous improvement and utilise problem solving tools and MPS (Merck Production Systems)
* Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues
Requirements:
* Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations
* At least 5 years working knowledge in the biotech industry with specific understanding of QA operations an advantage as well as Regulatory agency engagement
* Evidence of leadership skills coupled with good oral and written communication skills
* Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
* Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment
Key Skills:
Regulatory Compliance Specialist