We're looking for a candidate to fill this position in an exciting company.
- Leads and manages laboratory calibration program and ensue timely completion.
- Compiles data to trend and monitor key department performance metrics and provides reports to Quality Director
- Manages Laboratory Investigation Reports for any applicable nonconformances. Works with other departments and leads QC investigations to ensure accuracy and completeness of out-of-specifications, out-of-trends, deviations, and non-conformances
- Oversees the training and qualification of laboratory staff on newly written or revised methods and procedures
- Ensure compliance to the regulatory and the company's data integrity requirements.
- Acts as the primary point of contact for laboratory investigations information with internal and external auditors and regulatory inspectors.
- Expertise with cGMP manufacturing knowledge, and ISO / Health Canada/FDA/EMA regulatory requirements for cosmetic, NHP & OTC products.
- Demonstrated experience with creating and implementing effective Laboratory Information Management System (LIMS) , inclusive of writing SOPs and QC record review; facilitating and closing investigations, deviations and associated CAPA's
- In depth understanding and application of industry standards and cGMP/GLP guidelines.
- Experience in implementation of LIMS
- Professional certification as Certified Quality Manager will be an asset
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills