Quality Engineer/Manger Job at Katalyst Healthcares & Life Sciences
KEY KNOWLEDGE/ SKILLS AND COMPETENCIES:
KEY RESPONSIBILITIES:
The position is responsible to ensure the successful execution of, but is not limited to, the following:
MINIMUM QUALIFICATIONS:
PREFERRED QUALIFICATIONS:
- Risk Management experience
- Investigation, CAPA, and Change Control experience
- Experience in developing leading quality system metrics
- Lean/Six Sigma certification or understanding of Lean principles
- Excellent technical writing, presentation, and communication skills
- Ability to thrive in a high throughput environment
- Project Management experience
- Collaboration / Teamwork / Conflict Management
- Ability to independently support cross-functional teams and represent the Quality unit
- Communication/ Influencing
- Ability to effectively influence others within technical area of expertise
- Ability to communicate effectively across all organizational levels
- Critical Thinking / Problem Solving
- Ability to evaluate quality matters and make decisions utilizing risk-based approach
- Flexibility/Adaptability
- Attention to details.
- Global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
- Knowledge of ASTM E2500, CSV/GAMP, ICH Q9 and other associated standards
- Demonstrated ability to work independently to provide QA support for large, multifaceted projects
KEY RESPONSIBILITIES:
The position is responsible to ensure the successful execution of, but is not limited to, the following:
- Compliance Initiatives
- Responsible for CAPA management – accountable for on time completion and effective CAPAs at the site
- Responsible for change management – accountable for on time completion and effective changes at the site
- Development of leading metrics and advancement of reporting for operational review
- Buildout process for site risk management – to include gap assessment evaluation from inspections.
- Proactively monitor site compliance metrics to ensure meeting/ exceeding expectations.
- Participate in continuous improvement initiatives.
- Including projects resulting from value stream mapping activities
- Support team projects as needed (e.g: Quality Agreement process improvements, training enhancement and others as identified)
- Real-time Inspection Readiness
- Provide feedback to site Inspection Readiness Plans associated with regulatory filings.
- Participate in and follow up on activities from compliance walkthroughs.
- Individual Development and Training
- Responsible for timely completion of trainings, goal development, self-evaluation and IDP
- Represents Company Quality on cross-functional working teams, applying strong communication and collaboration skills.
- Identify areas of improvement and participate in process improvement initiatives
- Additional as needed support to processes, systems, procedures to ensure continuous Quality improvement
- Additional activities as needed to support the Company Manufacturing Center Operational Quality Team.
- Author/Revise Standard Operating Procedures
MINIMUM QUALIFICATIONS:
- Bachelor's degree in a scientific or allied health field and 8+ years of relevant work experience, or master's degree with 5+ years relevant experience, or relevant comparable background
- Candidate must have experience in a Quality Assurance role supporting or relevant experience
- Demonstrated success independently leading cross-functional projects
PREFERRED QUALIFICATIONS:
- Inspection support roles
- Quality System background
- Conducting investigations, performing Root Cause Analysis and identifying CAPA
- Drug product (oral solid dosage forms preferred) development and manufacturing.
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