Associate Manager Quality Assurance RA

Advantage Solutions - Markham, ON (il y a 30+ jours)

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Summary

Associate Manager QA RA

The Associate Manager of Quality Assurance (QA) & Regulatory Affairs(RA) will be responsible for all QA & RA functions including, but not limited to batch/lot record review and release, raw data review, deviation/failure investigation, change evaluation, product sampling, and retention as it relates to Drugs, Natural Health Products, Medical Devices and Cosmetics that are imported and/or distributed by the company in Canada.

Responsibilities

Advantage Sales and Marketing LLC dba Advantage Solutions is one of North America’s leading sales and marketing agencies specializing in outsourced sales, merchandising, category management and marketing services to manufacturers, suppliers and producers of food products and consumer packaged goods. Advantage Solutions services a variety of trade channels including grocery, mass merchandise, specialty, convenience, drug, dollar, club, hardware, consumer electronics and home centers. We bridge the gap between manufacturers and retailers, providing consumers access to the best products available in the marketplace today.

Essential Job Duties and Responsibilities

Job Duty

Quality Assurance:
  • Conduct a review of and track Good Manufacturing Practices (GMP) documentation, including Master Batch Records, Certificates of Analysis, Annual Product Quality Reviews, Stability, etc., for products marketed.
  • Performs all QA functions including, but not limited to: batch/lot record review and release, raw data review, deviation/failure investigation, change evaluation, product sampling, and retention.
  • Reviews production and laboratory records, assisting in internal audits and self-inspections.
  • Supports in the development of SOPs to ensure efficient and compliant External Quality function.
  • Perform Quality Control duties as stated in the Standard Operating Procedures on Quality Control.
  • Ensure that all medical device, drug, natural health product and cosmetic products released is of intact product integrity.
  • Liaison with the suppliers of the Advantage Solutions Inc.’s medical device and/or drug and/or natural health and/or cosmetic products.
  • Liaison with third party Quality and Regulatory Designate.
  • Liaison with the contract warehouse as it pertains to the Advantage Solutions Inc.’s medical device, drug, cosmetic and natural health products.
  • Always adhere to the Standard Operating Procedures for the Good Manufacturing Practices operations of Advantage Solutions Inc.
  • Maintain accurate GMP records for the product.
  • Ensure that no medical device, drug, cosmetic and natural health products is released for sale unless it is in compliance with the GMPs.
Regulatory Affairs:
  • Keep an up-to-date knowledge on company and Health Canada regulations and policies applying appropriate implementation strategies where required.
  • Reviews regulatory documentation and submissions to regulatory bodies including, but not limited to: Drug Establishment Licenses, and Site Licenses/registrations.
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Supervisory Responsibilities

Direct Reports

  • This position does not have supervisory responsibilities for direct reports
Indirect Reports

  • This position does not have guidance or mentoring responsibilities for indirect reports
Travel and/or Driving Requirements

  • Travel and Driving are essential duties and function of this job
  • Travel up to 5%
Minimum Qualifications The following are the minimum job-related qualifications which an individual needs in order to successfully perform the essential duties and responsibilities of the job

Education Level: (Required): Bachelor's Degree or equivalent experience

Field of Study/Area of Experience:
5+ Years of experience in compliance, quality assurance, regulatory affairs, and document management in the pharmaceutical or non-prescription drug industry or equivalent
Experience in an environment adhering to federal governmental regulation (i.e: Health Canada)
Strong GMP pharma/ Qualified Person in Charge (QPIC) experience.
Prior experience interacting with auditors and regulators.
Experience in document control and management.
Experience with preparing regulatory submissions is an asset.

Skills, Knowledge and Abilities

Strong ability to understand and analyze technical documents, processes, regulations, industry standards, procedures, and processes.
Excellent communication skills.
Analytical, methodical and diligent with outstanding planning abilities.
Ability to effectively work both independently and in a team environment.
Superior time management and organizational skills.
Excellent knowledge of current good manufacturing regulations as applicable to the pharmaceutical industry, specifically Health Canada.
Superior leadership skills.

Environmental & Physical Requirements

Office / Sedentary Requirements

Incumbent must be able to perform the essential functions of the job. Work is performed primarily in an office environment. Typically requires the ability to sit for extended periods of time (66%+ each day), ability to hear the telephone, ability to enter data on a computer and may also require the ability to lift up to 5 kilograms.

Additional Information Regarding ASM Job Duties and Job Descriptions

The Company is committed to providing equal opportunity in all employment practices without regard to race, nation or ethnic origin, colour, religion, age, sex (including pregnancy and childbearing), sexual orientation, marital status, family status, physical or mental disability or pardoned criminal convictions, or any other category protected by law.

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. The Company reserves the right at any time with or without notice to alter or change job responsibilities, reassign or transfer job position or assign additional job responsibilities. Advantage Solutions shall provide reasonable accommodations of known disabilities to enable a qualified applicant or employee to apply for employment, perform the essential functions of the job, or enjoy the benefits and privileges of employment as required by the law.

Employee understands that neither the provision of the Job Description nor any representation in this document creates a guarantee or contract of employment for any specified period of time or changes the nature of Employee’s employment, which can only be modified in a writing signed by the CEO.

Important Information

The above statements are intended to describe the general nature and level of work being performed by people assigned to this position. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of associates so classified.

The Company is committed to providing equal opportunity in all employment practices without regard to age, race, color, national origin, sex, sexual orientation, religion, physical or mental disability, or any other category protected by law. As part of this commitment, the Company shall provide reasonable accommodations of known disabilities to enable an applicant or employee to apply for employment, perform the essential functions of the job, or enjoy the benefits and privileges of employment as required by the law.

The Company welcomes and encourages applications from people with disabilities. The Company will provide reasonable accommodations, accessible formats and communication supports upon request to persons with disabilities who take part in all aspects of the recruitment and selection process. If you require accommodation in connection with the application process, please contact: Recruiter, Talent Acquisition, for external applicants, or, a Supervisor for internal applicants.