What are the responsibilities and job description for the Pharmaceutical Quality Expert position at Suru?
Job Overview
We are looking for a highly qualified Pharmaceutical Quality Expert to join our team at Suru. This role involves ensuring compliance with international pharmaceutical and biotechnology regulations, with a strong emphasis on maintaining and improving quality systems.
Responsibilities:
- Ensure adherence to global regulatory requirements, including ISO standards and FDA regulations, to maintain product quality and compliance.
- Develop, review, and manage complex technical documentation related to quality processes and regulatory compliance.
- Oversee and contribute to critical quality system functions such as process improvements, non-conformance investigations, regulatory audits, and validation efforts.
- Apply statistical process control (SPC) techniques and industry best practices to analyze and optimize manufacturing and quality control processes.
- Leverage extensive industry experience and critical thinking to guide decision-making and strategic planning for quality initiatives.
- Demonstrate strong organizational and planning abilities to manage multiple projects and priorities effectively.
- Communicate clearly and professionally across departments, as well as with external partners, to ensure alignment on quality objectives and compliance requirements.
- Collaborate within cross-functional teams to drive continuous improvement and maintain a high standard of quality.
- Utilize expertise in quality management systems, including deviation handling, document control, product release, and change management, to support business objectives and mitigate risks.
Requirements:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 3-7 years of experience in quality assurance, with a focus on documentation and compliance in regulated industries such as pharmaceuticals or medical devices.
- In-depth knowledge of industry regulations, including ISO 9001, ISO 13485, and FDA 21 CFR Parts 210, 211, and 820.
- Strong background in managing quality systems, including CAPA, audits, process validation, and change control.
- Proficiency in statistical analysis and SPC methodologies to support quality improvements.
- Excellent analytical and problem-solving skills with a keen attention to detail.
- Exceptional written and verbal communication skills with the ability to work effectively across teams and with external partners.
- Proven ability to work independently and collaboratively in a fast-paced, team-oriented environment.
