6100 Royalmount Avenue, Montréal, Quebec, Canada H4P 2R2
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LQC-Laboratoire de Qualité et Conformité
6100 Royalmount
Montréal, Québec
Canada H4P 2R2

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LQC votre partenaire dans la croissance et la stabilité de vos opérations LQC-Laboratoire de Qualité et Conformité grandi rapidement d'innovation et l'expansion continue des tests de contrat analytique et de l'organisation de conseil offrant BPL / BPF contrôle qualité (CQ) et la recherche et développement (R & D) analyse globale supérieure et inégalée pour soutenir l'industrie pharmaceutique, biopharmaceutique, industries nutraceutiques, cosmétiques et alliées.

En raison de notre croissance continue, nous sommes constamment à la recherche de professionnels qualifiés pour rejoindre une équipe engagée à l’excellence.

LQC à d'excellent produit la croissance explosive de la société résultant dans des ouvertures immédiates pour les professionnels suivants :

Senior Laboratory Analyst

Analytical Experience in Pharmaceutical, Nutraceutical, and Cosmetic Disciplines are a must for this position
Reports To: Laboratory Supervisor
Location: Montreal, Quebec

The successful candidate will be working in a very fast paced environment by performing full analytical testing of assigned materials or products within standard times and under minimal guidance/supervision. This position relies heavily on comprehensive wet chemistry techniques, Dissolution, HPLC, GC, AA testing on raw materials, in-process and final products per established SOP's and pharmacopoeial product specifications.

Duties shall include, but are not limited to, the following:

  • Document and report results in accordance with GMP and GLP
  • Conduct laboratory investigation as required
  • Provide technical support to other analysts
  • Perform trouble-shooting on complex issues with respect to laboratory analysis and laboratory instrumentation
  • Perform all work in accordance with all established regulatory, compliance and safety requirements
  • Train junior analysts as required
  • Maintain professional relationship with Internal/External Customers
  • Any ad-hoc tasks assigned by the QCL management

Qualification:

  • Permanent residency and/or Canadian citizenship
  • Sc. degree in Chemistry or related discipline is a must
  • Minimum of 5 years Quality Control experience in the Pharmaceutical/Nutraceutical discipline, ideally in contract testing
  • Knowledge of GMP, GLP, Compendia, analytical techniques and method validation
  • Superior organizational and interpersonal skills
  • Ability to manage multiple projects concurrently and effectively
  • With GC experience
  • Sound theoretical and technical knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, AA, TOC
  • Sound understanding of cGMP, ICH and FDA requirements
  • Excellent written and oral communication skills is a must
  • Computer proficiency with MS Office programs
  • Ability to meet deadlines and prioritize tasks with strong attention to detail

The above positions are only applicable to permanent residence and/or Canadian citizens with a minimum degree in science and five years of direct experience.

To Apply, Click on the Apply Now icon to submit your resume (in Microsoft Word format).
We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.

or Forward your resume to the attention of Human Resources to jobs@qctest.com

Senior Quality Assurance Specialist

Experience with Pharmaceutical Industry is required

Reports To: Manager of Quality
Location: Montreal, Quebec

Primary Responsibilities:

Outstanding opportunity for Quality Assurance professionals to join our company based in Montreal as Senior Quality Assurance Specialists. As the Quality Assurance Specialist you will be responsible for the maintenance of the QA function and ensuring compliance according to GMP (Good Manufacturing Practice), and will perform activities to assure compliance with applicable regulatory requirements by conducting audits, supporting training programs, data and documentation reviews and analysis.

Responsibilities:

  • Manage the GMP Documentation, Change Control, CAPS, OOT, OOS, Training Record systems.
  • Review and approve CoA and other quality documentation
  • Review validation activities
  • Assess regulations
  • Develop quality policy
  • Perform timely data review with a high focus on data quality to ensure accuracy and completeness of analytical testing documentation.
  • Oversee Quality Control documentation to enforce good documentation practice to improve accuracy, GMP compliance and neatness of analytical documentation
  • Verify calculations and documented information such as reagent expiry, instrument calibration, logbook entries, control charts etc are present and complete and accurate.
  • Review internal logbooks for incoming samples, standards, reagents, equipment etc.
  • Issue and reconcile Quality Control laboratory workbooks and other GMP documentation.
  • Audit and inspect laboratory equipment daily use logbooks
  • Ensure analysis performed are as per client’s specification
  • Track tests in progress and issue periodic status reports
  • Support training initiatives by implementing training program, including monitoring effectiveness of program and ensure training records are compliant
  • Implement Quality Policies and Procedures for on-site test activities
  • Develop, implement and update QA Manual, QA Supplement Manual and standard operating procedures
  • Prepare, review and approve Standard Operating Procedures (SOPs)
  • Coordinate documentation activities to ensure compliance with GLP and GMP
  • Archive and retrieve quality control data
  • Audit and inspect laboratory operation and activities
  • Audit and review data for accuracy, completeness and regulatory compliance
  • Detailed audits of draft reports for compliance with SOP’s and GLP regulations
  • Participate in client audits and inspections
  • Participate in regulatory audits and inspections
  • Oversee the laboratory investigation
  • Perform Annual Internal Audit, and work with Analytical Lab personal to ensure follows up and corrective actions are completed.
  • Periodic review of training records, SOPs, Change Control implementation, Deviation and OOS investigation
  • Data-review and data-verification activities
  • Maintaining and issuing controlled numbers in support of site-wide document control
  • Tracking document requests and ensure completion of outstanding items
  • Conduct QA investigation with regard to Out-of-Specifications, Exceptions and Corrective Action. Monitor effectiveness of corrective and preventative actions.
  • Assist in the review and approval of GMP documents such as SOPs, and associated forms, and initiate revisions.
  • Evaluate laboratory results and keep trending of QCL Stability studies and write assessment reports of these programs annually.
  • Any other tasks assigned by the QLC senior management

Education and Experience:

  • University Degree in Science – preferably in Chemistry coupled with experience in the review of raw material, finished product, stability and analytical method validation documentation.
  • Have experience in a Quality Assurance leadership role with minimum of 3 yrs quality experience in a regulated pharmaceutical environment, within QA, QC, and/or Regulatory Affairs disciplines.
  • Have expert experience of GMP Thorough understanding of pharmaceutical QA Systems, US, EU, and Canadian GMP regulations
  • Knowledge of GMP, GLP, Compendia, analytical techniques
  • You should have excellent verbal and written communication skills, interpersonal skills and you should be extremely results driven and organized

General Skills:

  • The requirements listed below are representative of the knowledge, skill, and/or ability required.
  • Must be willing to work in a team-based environment
  • Must have solid math skills
  • Must be able to work with limited direct supervision
  • Must have good problem solving/organizational skills
  • Must have excellent computer skills
  • Must have strong writing and communication skills in English
  • Must have the ability to analyze data
  • Must be attentive to detail
  • Must have excellent organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required

The above positions are only applicable to permanent residence and/or Canadian citizens with a minimum degree in science.

To Apply, Click on the Apply Now icon to submit your resume (in Microsoft Word format).
We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.

or Forward your resume to the attention of Human Resources to jobs@qctest.com

Quality Assurance Data Reviewer

Location: Montreal, Quebec

Primary Responsibilities:

The successful candidate will perform activities to assure compliance with applicable regulatory requirements by conducting audits, supporting training programs, and data/documentation review.

Responsibilities:

  • Perform timely data review with a high focus on data quality to ensure accuracy, completeness, cGMP compliance, and neatness of analytical documentation
  • Verify calculations and documented information such as reagent expiry, instrument calibration, logbook entries, control charts, etc. are present, complete and accurate
  • Issue and maintain client CoAs
  • Issue and reconcile Quality Control laboratory workbooks and logbooks
  • Verify that all analysis performed were as per client's methodology and/or compendial methods, and were in compliance with GLP and GMP requirements
  • Support training initiatives and ensure training records are complete and compliant
  • Review Standard Operating Procedures (SOPs)
  • Archive and retrieve quality control data files
  • Audit and review data for accuracy, completeness and regulatory compliance
  • Assist in client audits and regulatory inspections as required
  • Review laboratory investigations conducted by Quality Control
  • Periodic review of training records, SOP’s, Change Control implementation, Deviation and OOS investigation
  • Assist in maintaining the Change Control system
  • Assist laboratory with regard to Out-of-Specification investigations, Exceptions and Corrective Actions
  • Other applicable tasks assigned by the QA manager

General Skills:

The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • Must be proficient at working in a team-based environment
  • Must demonstrate good written and oral communication skills in English (competence in French is an advantage)
  • Must have solid math skills
  • Must be able to work with limited direct supervision
  • Must have the ability to analyze data to extract pertinent information
  • Must be attentive to detail
  • Must have the flexibility to adapt to changing priorities
  • Must be able to manage multiple projects and tasks concurrently and effectively
  • Must have good organizational and interpersonal skills

Education and Experience:

  • University Degree in Science - Majoring in Chemistry
  • Experienced in the review of raw material, finished product, stability and analytical method validation documentation
  • Minimum of 2-5 yrs quality experience in a regulated pharmaceutical environment, within QA, QC, and/or Regulatory Affairs disciplines
  • Thorough understanding of cGMP, ICH, Canadian, and FDA regulatory requirements
  • Sound knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, Dissolution, AA, TOC
  • Computer proficiency with MS Office programs.

The above positions are only applicable to permanent residence and/or Canadian citizens with a minimum degree in science and five years of direct experience.

To Apply, Click on the Apply Now icon to submit your resume (in Microsoft Word format).
We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.

or Forward your resume to the attention of Human Resources to jobs@qctest.com