Prometic Bioproduction Inc. ("PBP") undertakes the development and manufacture of high-value plasma-derived therapeutic biosimilars for Prometic's current and future clients in a state of the art facility.
The Validation department of Prometic Bioproduction Inc. is looking for a Validation Specialist to work at its plant in Laval, Quebec. Under supervision of the Validation Manager, the Validation Specialist will be responsible for validation, qualification and calibration activities at Prometic Bioproduction Inc.
The mandate of the Validation Specialist will be mainly:
- Authors Installation Qualification, Operational Qualification and Performance (IQ/OQ/PQ) protocols in conjunction with manager;
- Perform equipment, system and facility Qualifications (IQ/OQ/PQ);
- Perform thermo-mapping activities and temperature distribution verifications;
- Perform appropriate testing for all qualification and requalification activities;
- Perform validation periodic review;
- Participate in the cleaning, shipping and computer and software validation programs;
- Write and/or revise SOPs, and maintain all validation related documentation;
- Ensure compliance of validation activities with the Good Manufacturing Practices (cGMP);
- Liaise with the QA dept. to produce and release documentation as required to fulfill the validation process under the Documentation Control Procedure;
- Ensure the quality system is in compliance with the Good Manufacturing Practices ("cGMP");
- Contact suppliers for validation or calibration services, purchasing and troubleshooting;
- Other related duties/responsibilities as assigned by the Supervisor.
The selected candidate will hold a Bachelor degree in Biochemistry, Biology, Chemistry or related field combined with a minimum of two (2) to three (3) years of knowledge and working experience with all aspects of validation and quality assurance acquired in the pharmaceutical industry. Experience with biologics or biotechnology derived products is required. The candidate must have a trough knowledge and understanding of Canadian, US FDA and European regulations (GMP) combined with experience with GLPs, GCPs and ICH regulations and guidelines. Bilingualism is essential, (French and English) both oral and written. The person must demonstrate ability to operate both independently and in cross-functional team settings including qualified professionals of other departments.
The following criteria are also required:
- Attention to detail;
- Critical thinking skills;
- Team player;
- Quality awareness;
- Planning and organizing;
- Good communication and interpersonal skills;
- Analytical ability.
Prometic offers a competitive compensation, a flexible work schedule and a casual working environment.
To apply, please send a cover letter and copy of your resume to HR with the following reference: PBP-VAL-1701. Prometic is an equal opportunity employer. Only chosen candidates will be contacted for an interview. For more information about Prometic, visit our website www.Prometic.com.