Key Account Manager
Eurofins Experchem Laboratories is a government-accredited, industry-leading laboratory that specializes in pharmaceutical product testing and regulatory affairs consulting and have been in business for 30 years. As a government-licensed drug-testing facility, we do chemical and microbiological testing of raw materials and finished products. In 2015, Experchem Laboratories was acquired by Eurofins Scientific. Eurofins Scientific is a leading international group of laboratories providing an unparalleled range of testing and support services to the pharmaceutical, food, environmental and consumer products industries and to governments, with over $2 billion in annual revenues and 22,000 employees across 300 sites in 39 countries.
We are looking to fill a position within our Consulting department for a Key Account Manager, reporting to the President. This is a permanent, full-time position with the requirement of working Monday to Friday during core business hours.
- Liaise with the product suppliers to ensure proper receipt of required documentation;
- Liaise with the Head Office QC Designate and Warehouse QC Designate;
- Liaise with the warehouse as it pertains to the regulated products to ensure that Cleaning/Sanitation Procedures, Pest Control Procedures and Warehouse Environmental Monitoring are adhered to;
- Liaise with Health Canada on matters involving the client’s activities as they pertain to their regulated products;
- Ensure the receipt and compliance of GMP Documents (including, but not limited to, master fabrication and packaging documents, test methods, specifications, certificates, batch records, annual product quality review, validation studies, transportation studies, mapping studies, stability studies);
- Coordinate Canadian confirmatory testing for imported products;
- Reconcile GMP documents for product lots requiring QC disposition (Batch records, Certificate of Analysis and Certificate of Manufacture, Product Label Reviews);
- Generate and Approve Finished Product and Stability Specifications;
- Generate and Approve validation documents (including but not limited to, method, cleaning and process protocols and reports);
- Generate and Approve protocols and reports for transportation, temperature mapping or stability studies (including, but not limited to, long-term, accelerated and freeze-thaw);
- Generate and Approve overlabel orders; review and approve any overlabelling of product;
- Coordinate, assess, trend and evaluate results from drug and natural health product stability programs to ensure compliance;
- Determine the disposition of damaged goods;
- Determine the disposition of returned goods;
- Coordinate and track the destruction of samples, to ensure product is adequately destroyed;
- Review and determine status of warehouse reports;
- Compile required GMP documents for the evaluation of complaints;
- Log, review and determine status of complaints;
- Lead the reporting of adverse events, drug reactions, and recalls; serve as the recall coordinator in the event of a recall;
- Conduct sample handling and label review; Ensure that products received are transported, handled, sampled, stored, and destroyed correctly;
- Coordinate self-inspections and external inspections;
- Provide representation on quality issues for clients at inspections conducted by regulated bodies and customers;
- Coordinate the ongoing tracking and maintenance of GMP documents;
- Coordinate the training of new staff, and ensure all employees involved in the handling of regulated products are trained;
- Ensure training records and associated reports are satisfactory;
- Ensure deviations and out-of-specification investigations are conducted appropriately;
- Ensure Corrective Action and Preventative Action (CAPA) investigations are conducted appropriately;
- Ensure that all levels of change are evaluated and documented;
- Adhere to the clients’ Standard Operating Procedures;
- Write and modify clients’ Standard Operating Procedures to ensure they remain current with practices and regulations;
- Ensure all required staff is trained on clients’ Standard Operating Procedures;
- Ensure that all staff members are following the Standard Operating Procedures at all times;
- Ensure GMP agreements and contracts are accurate, signed and adhered to by all parties involved in the GMP work for each client;
- Ensure that all product released is of good quality and in compliance with GMPs;
- Ensure that the required quality testing is performed on all products for Finished Product Testing, Stability Testing, and as per product-specific regulations;
- Maintain the current Licences (including, but not limited to: Drug Establishment Licence, Site Licence, Medical Device Establishment Licence, Drug Identification Number);
- Maintain current foreign site information;
- Ensure that the health of employees do not put the operations and other employees at risk for health concerns;
- Oversee and advise on pharmacovigilance activities. Ensure annual reports are conducted.
- Ensure accurate inventory control and distribution records.
- Attend and Chair staff meetings;
- Management of billing software and staff time review for billing purposes;
- Prepare letters to clients and/or regulatory authorities as required;
- Delegate GMP tasks to QC Associates or Co-op students;
- Other duties are required by Supervisor.
- Bachelor's degree in science (preferably Chemistry); certificate in Regulatory Affairs or pharmacovigilance is an asset
- 2+ years working directly with clients in a lab environment
- 2+ years working with Health Canada
- Bilingual (French/English) strong asset
Accommodation: Persons with disabilities who need accommodation in the application process, or those needing job postings in an alternative format, may e-mail a request - submit request.
Submit your resume via email: APPLY NOW
We thank all applicants for showing an interest in this position. Only those selected for an interview will be contacted. No agencies please!