Job Description
Reporting to the Quality Assurance Corporate Director located in France, you will work closely with department heads in Quality Assurance, Pharmacovigilance, Materiovigilance, and Regulatory Affairs to provide scientific, quality, and regulatory guidance.
You will be based at our subsidiary's head office in Montreal. Some travel to France is to be expected.
Quality Management :
- Contributes to maintaining the MacoPharma Quality system locally,
- Contributes to the implementation of deviations, corrective and preventive actions and change controls,
- Manages inspections/audits from Authorities and Customers and does the follow up of actions,
- Contributes to SOP Management by issuing new SOPs and revise existing SOPs Product release for drugs on the Canadian territory,
- Performs supplier and internal audits,
- Performs the regulatory and normative watch for Canada,
- Acts as local Responsible Person (RP for GDP) for Canada, Person Responsible for Regulatory Compliance).
Regulatory Affairs :
- Coordinates contact between national regulatory body and MacoPharma head office regulatory department,
- Manages any local regulatory issues and respond to questions regarding MacoPharma Canadian product registration,
- Ensures compliance with national legislation,
- Keeps and checks compliance of local registration files including approval of documents.
Complaints and Vigilance:
- Acts as local Qualified Person for Pharmacovigilance in Canada :
- Coordinates PV activities in close interaction with headquarters
- Establishes and maintains the MACOPHARMA Canada PV system that complies with the requirements of the Marketing Authorization(s) as defined in the Canadian legislation and guidelines
- Works with the head office materiovigilance department in coordinating response to customers for complaints and vigilance incidents,
- Is the direct contact with final customer for quality, complaints, vigilances, documentation requested. This may include customer facing activities such as occasional defect reviews at customer sites with Macopharma team members,
- Contributes to answering request from Competent Authorities.
#MacoRecrute
-Higher education science
-2 to 5 years’ experience in QA or regulatory, pharmaceutical or medical device industry
-Knowledge of Canadian regulations for drugs and medical devices
- Strong communication skills
-High level of English and French communication (spoken and written)
-Ability to work with autonomy, in small team within a large international organization
-Good analytical and synthesis skills
-Be rigorous