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Document Control Specialist

May 3 2017
Industries Pharmaceutical, Biotechnology
Categories Administrative Support, Health - Safety - Environment, Quality assurance and control - Validation
Saint-Laurent, QC

The Company

enGene Inc. is a high growth biotechnology company developing a robust, proprietary non-viral vector platform to deliver genes to mucosal cells lining the gut. The vector system can be administered to the intestine via the oral or enema route. enGene is developing its unique gut-optimized gene delivery formulation into an orally available "Gene PillTM", which has the potential to be a platform for oral delivery of a wide range of protein drugs. The Company's primary focus is to apply its technology to enable localized delivery of immune-modulating proteins to the gut for treating various immune disorders.

Strategic Pharma Alliances and Investors

With its exciting cutting edge technology, enGene successfully established alliances with two international large pharmaceutical companies: Johnson & Johnson and Takeda Pharmaceutical Company.

enGene is also supported financially by top-tier institutional investors including Forbion Capital Partners, Fonds de Solidarité FTQ, Lumira Capital, Pharmstandard International S.A. and Johnson & Johnson Development Corporation. 

Role

 

enGene is seeking a Document Control Specilist with background in development & manufacturing of therapeutics  to be an integral part of the Quality Assurance team.  This position reports directly to the Director of Quality Assurance.

 

This person will be responsible for the the overall  document lifecycle management.

 

Essential Duties and Responsibilities

 

This person will:

  • Maintain, process, and shepherd all documents, training, equipment records through their respective lifecycles on a daily basis as assigned and according to work instructions and SOPs;
  • Create/issue/maintain forms, logs, SOPs, work instructions, document numbers, master labels, etc. (including but not limited to SOPs, protocols, methods, reports, batch records, specifications);
  • Propose, update templates and work instructions when necessary; proactively apply standards and ensure consistency across all controlled documentation
  • Meticulously track and file all controlled documentation;
  • Retrieve and respond to requests for information securely and in a timely manner; negotiate revisions with originators in a professional manner;
  • Assist in preparation for customer audits and regulatory inspections;
  • Review documentation to assure accuracy, completeness and absence of errors;
  • Perform reconciliation and closing of batch records;
  • Coordinate the creation, revision, and distribution of controlled documents within respective departments;
  • Assign control numbers to Document Change Requests;
  • Assist in trending of quality issues.

 

 

Required experience and qualification

  • Bachelor's degree is preffered
  • A minimum of 5 years of experience in pharmaceuticals or biologics.
  • Minimum of 3 years relevant work experience in document control management
  • Working knowledge of cGMPs, Health Canada and FDA regulations as it pertains to document control

 

Skills

 

The candidate will have the following competencies necessary for this position:

  • Ability to work in extremely fast paced environment
  • Ability to make sound decisions while meeting project deadlines
  • Proficiency in Sharepoint
  • Ability to work autonomously
  • Effective team working skills with cross-functional teams
  • Ability tro handle confidential information
  • Good interpersonal skills
  • Strong English writing skills (French verbal skills are an asset).

 

enGene Inc Contact

 

Please reply to *******@*********.com with "Document Control Specialist" in the subject line. 

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