Job details QA Compliance Specialist

Posting Period

From September 27, 2021
to October 29, 2021

Country or region

Canada

Location

Mirabel, Québec

Business Unit

Health Solutions

Department

Quality Assurance and Control

Entry date

As soon as possible

Job Status

Permanent - Full time

Minimal required work experience

4 to 5 years

Minimal education level required

DEC

Work schedule

 Schedule of 37.5 hours per week, Monday to Friday

Salary

Based on experience

Benefits

Competitive social benefits

QA Compliance Specialist

Main Functions

Reporting to , Lallemand Health Solutions (LHS) Quality Assurance Director, the Quality Assurance Compliance Specialist will mainly be involved in quality systems management and in the improvement activities related to compliance of the plants.

 

 Responsibilities 

  • Participate in the implementation, improvement and management of quality systems;
  • Participate in the implementation, revision and follow-up of quality agreements;
  • Ensure routine monitoring of supplier qualifications and requalifications;
  • Coordinate and ensure client questionnaires are duly completed;
  • Participate in special projects contributing to the improvement of internal and/or sub-contracted systems and processes;
  • Participate in the harmonization or updating of the quality systems of the plants through routine monitoring or within the context of a project;
  • Participate and monitor compliance to regulatory requirements;
  • Research, monitor and evaluate industry regulatory requirements and established standards related to good manufacturing practices (GMPs);
  • Participate in risk assessments and the issuance of position paper guidance documents for special mandates. As appropriate, assist in the development of corrective and / or preventive measures and promote continuous improvement initiatives;
  • According to the nature of the project, participate in investigating or evaluating deviations, change controls, non-conformances, etc.;
  • Monitor and assure proper completion of LHS inter-site CAPAs;
  • Collaborate with the departments and teams to find solutions to corrective and preventive actions. Collaborate as a support role to operations;
  • Act as a support to the plants’ quality assurance teams when needed;
  • Participate in committees when required;
  • Write and update standard operating procedures (SOPs) and other technical documents related to LHS quality assurance policies;
  • Participate in various audits (routine inspections, internal audits, qualification of suppliers, external audits, customer audits, regulatory audits, etc.) as needed;
  • Monitor and evaluate trends for key performance indicators and carry out required and appropriate follow-ups;
  • Interact with LHS plants as well as with customers and regulatory authorities when required;
  • Any other related tasks.

Technical skills

Required

  • Holds at minimum a college diploma in science
  • Has at least five (5) years of experience in a similar position in the biotechnology or pharmaceutical industry
  • Has an excellent understanding, ability to interpret and adapt regulations and standards (GMP, HACCP, FSMA, etc.)
  • Excellent oral and written communication skills, in both French and English;
  • Excellent computer skills (Excel, Word and PowerPoint).

An asset

  • Project management skills would be an asset;

Personal abilities

Required

  • Strong organizational and interpersonal skills;
  • Strong organizational and interpersonal skills;
  • Displays good judgment and is rigorous;
  • Has a very good problem-solving ability and able to work on multiple projects

General criteria

Required

  • Available to travel outside the country and on other plants (10-20% of the time);

Organization

Lallemand is a privately held Canadian company founded in the late 19th century, which develops, produces, and markets microorganisms for various markets. The administrative offices of the parent company are in Montreal, Canada. Today, Lallemand employs more than 4,500 people working in more than 45 countries on 5 continents.

Lallemand Health Solutions specializes in the production of probiotics intended to serve the agri-food, parapharmaceutical, and pharmaceutical industries. With its manufacturing processes adhering to the highest standards of quality, the company provides probiotic strains that help millions of people improve their health and well-being.

On top of its extensive portfolio of ready-to-use probiotics (Lacidofil®, Probiokid®, Probio'Stick®, Protecflor®), the Health Solutions branch also tailor-makes unique formulas to respond to clients' unique needs. This process employs the Harmonium, Lafti®, or Rosell® strains.

The Lallemand Health Solutions team enjoys a stellar reputation, as one of the only companies that is authorized to produce the S.boulardii strain. Whether in North America, Europe, or Asia, your next pro-fessional challenge awaits you at Lallemand!

Please take note that accommodations will be provided in all parts of the hiring process. Applicants need to make their needs known in advance.

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