What are the responsibilities and job description for the Quality Engineer position at Planet Pharma?
The Quality Engineer will have in-depth knowledge of films and foils materials and experience ensuring the quality, safety, and compliance of packaging materials used in pharmaceutical products. Added knowledge of blister packaging machines is a plus. This role focuses on product quality control, regulatory compliance, and continuous improvement with a strong emphasis on quality and cost management.
- Operations Quality Management: Oversee quality related to the production of films and foils for primary packaging applications, ensuring strict adherence to pharmaceutical industry standards.
- Quality Control Analysis: Set up quality control analysis to confirm they meet required specifications and safety standards.
- Cross-functional Collaboration: Work closely with Production, Development and technology, Supply Chain, Safety, Quality Assurance and Regulatory affairs, and other teams to ensure the quality and integrity of packaging materials throughout production and post-production.
- Continuous Improvement: Monitor production processes, identify opportunities for improvement, and drive initiatives to optimize quality and minimize cost.
- Regulatory Compliance: Ensure compliance with cGMP, ISO 9001, ISO 15378, and other relevant standards. Lead efforts to meet regulatory requirements and quality benchmarks for pharmaceutical packaging materials.
- Requirement Analysis & Validation: Conduct requirement analysis, process validation, and system validation to ensure alignment with quality standards.
- Supplier Quality Management: Manage supplier quality processes, standardize inspection systems for incoming raw materials, in-process checks, and final inspections.
- Customer Complaints Management: Analyze customer complaints related to packaging materials and implement corrective and preventive actions to resolve issues.
- Technical Support: Provide technical expertise to troubleshoot production issues related to films and foils and assist in resolving production-related challenges.
- Industry Awareness: Stay up to date with the latest trends and technological advancements in polymer science, packaging technologies, and industry best practices.
Bachelor's degree in Polymer Science, Chemical Engineering, or a related field; Master's degree preferred.
Minimum of 5 years in quality engineering or polymer science, specifically with a focus on packaging materials in the pharmaceutical industry. Blister packing machines knowledge is a bonus.
Strong understanding of films and foils properties, processing methods, and their applications in pharmaceutical packaging.
Experience in quality control testing and assurance practices within the packaging industry.
In-depth knowledge of GMP (Good Manufacturing Practices) and other relevant regulatory requirements for pharmaceutical packaging.
High-level analytical and problem-solving abilities to address production issues and drive process improvements.
Excellent verbal and written communication skills, with the ability to work effectively across various departments and stakeholders.
Ability to work independently, manage multiple projects simultaneously, and prioritize tasks effectively.
Strong interpersonal skills and the ability to work collaboratively in a team-oriented environment.
Salary : $90,000 - $110,000
