Lead Quality Investigator - Eurofins Alphora
Eurofins Scientific is a world leader in the food, bio/pharmaceutical product testing, as well as environmental laboratory services and one of the global market leaders in agroscience, genomics, discovery pharmacology, and central laboratory services. With over $2 billion in annual revenues and 38,000 employees across 400 sites in 44 countries, Eurofins is a leading international group of laboratories providing an unparalleled range of testing and support services to the pharmaceutical, biopharmaceutical, food, environmental, and consumer products industries and to governments.
Eurofins Alphora is a pharmaceutical research, development and manufacturing organization in the field of active drug substances and synthetic organic chemistry. Alphora’s focus is at the early stage of API Technology Development, developing chemical processes and preparing materials for pre-clinical and clinical studies. As well, Alphora provides transformative process chemistry expertise for later stage programs and niche commercial manufacturing. Alphora has state of the art synthetic R&D labs, analytical services, GMP Kilo Labs, GMP Pilot Plant and supporting QC/QA functions. Please refer to our website for further information on this Eurofins company.
The Lead Quality Investigator is accountable to the Director, Quality and Compliance to oversee the investigation program, evaluate the program for trends and ensure CAPA are appropriate and implemented at Eurofins Alphora Research. The Lead Quality Investigator is also responsible to lead and participate directly in the investigations of Deviations and Non-Conformances.
DUTIES AND RESPONSIBILITIES:
- Follow Environmental, Health and Safety rules/regulations and report any workplace injuries or accidents immediately.
- Adhere to the policies and guidelines set out in the Alphora Employee Handbook.
- Responsible for compliance with GMP guidelines and ensuring that all GMPs and SOPs are followed.
- Work harmoniously with all fellow employees.
- Ensures that all activities related to the recognition, investigation and resolution of all non-conformities (Out of Specification, Out of Calibration, Deviation, Non-Conformance etc.) are performed on a timely manner and in compliance with company and regulatory requirements. Lead and participate directly in the investigation of Deviations/Non-Conformances.
- Lead and participate directly in the investigation of Deviations / Non-Conformances.
- Reviews and evaluates for completeness and compliance of the investigation reports and resolution plans authored by Subject Matter Experts (SMEs).
- Maintains the Database, and uses it for tracking and trending activities.
- Identifies recurring Deviations /Non-Conformances and ensures appropriate actions are taken.
- Follows up and verifies that corrective / preventive actions are appropriate, are implemented as planned and have the intended effectiveness.
- Ensures Corrective & Preventative Actions are appropriate, are implemented as planned and have the intended effectiveness.
- Provides training related to CAPA, Root Cause Analysis and quality investigations to Alphora personnel.
- Perform other related duties as required.
COMMUNICATION AND CONTACTS:
Within the Company
- Interacts with All Departments across the organization.
Outside of the Company
- Interacts with clients
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We thank all applicants for their interest, however only shortlisted candidates will be contacted. No agencies please!