Search the 6 jobs at PharmaLex

The Engineer role involves characterizing process optimization strategies and troubleshooting operational issues in a manufacturing environment. Responsibilities include applying engineering principles for system modifications and experiments, analyzing results, and writing technical evaluations to support packaging component use.

The Sr Supplier Qual Engineer is responsible for ensuring suppliers deliver quality parts and materials. They qualify suppliers, monitor parts through the manufacturing cycle, resolve supplier-related issues, and conduct regular audits to ensure compliance with GMP and quality standards. This role requires effective communication with suppliers and internal stakeholders, as well as providing feedback on supplier performance.

The Quality Systems Specialist oversees quality programs and systems, ensuring compliance with policies and regulatory standards. They lead audit preparations, analyze processes for compliance, and facilitate quality assurance programs globally. Strong organizational and communication skills are required, along with the ability to implement process improvements.

Seeking experienced Contamination Control Auditors with expertise in Annex 1 projects to conduct gap assessments and report writing. Candidates should possess a Bachelor's degree in Microbiology, over 10 years in pharmaceutical Quality Operations, and strong knowledge of regulatory guidelines and cGMPs. Strong technical writing and communication skills are essential.

Design layout for activities such as machining, metal forming, plastics processing, welding, and assembly. Inspect machinery and equipment for efficiency and quality. Deliver and oversee projects from design to implementation. Mentor colleagues and ensure compliance with company standards.

The TMF Study Owner is responsible for ensuring consistent and compliant clinical trial documentation related to Trial Master Files. They lead the development of TMF specifications, monitor document quality, provide audit support, identify improvement opportunities, and collaborate with study teams to enhance documentation practices and regulatory compliance throughout clinical trials.