Highly Experienced Quality Professional Wanted
2 days ago
Job Title:
">- Quality Specialist
This role involves direct quality support to a production area as part of a Quality IPT (Integrated Product Team). The Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to cGMP and Documentation Practices, and represents quality on the shop floor. The Quality Specialist performs reviews of process documentation/data for accuracy, completeness, and data integrity compliance.
">Key Responsibilities:
">- ">
- Review/approve 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
- Provide 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 participate in the Tier process and use this forum to make issues visible and partner with the functional area on resolution
- QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment
- 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
- Participate 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
- Provide support to internal audits and regulatory inspections
- Collaborate 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 participate in continuous improvement initiatives to enhance operational efficiency and resolve issues">
Experience and Skills:
">- ">
- 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
- Seasoned professional with at least 5 years in the biotech industry with QA operations and regulatory engagement experience
- Evidence of leadership skills coupled with good oral and written communication skills
- Understanding of cGMPs and regulatory requirements as they apply to the pharmaceutical field or a related area
- Interpersonal skills including flexibility, collaboration and inclusion and ability to work in a team environment">
Preferred Experience and Skills:
">- ">
- Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents
- Analytical aptitude, critical thinking, and problem-solving skills
- Ability to upskill/coach others
- Experience working on manufacturing shop floor
- Familiarity with GMP documentation review and/or shop floor auditing">
Education:
">- ">
- Bachelor degree in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience">
Seniority level:
">- ">
- Mid-Senior level">
Employment type:
">- ">
- Full-time">
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