Associate II, QA Process Validation

Date: Apr 29, 2019

Location: Brantford, ON, CA, N3T 6B8

Company: Apotex

 

Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

 

Job Summary:

  • Keeps abreast and interprets new regualtions/guidelines, changes in GMP interpretation, emerging regulatory and industry trends, and informs Mangements of developments.
  • Uses sound, technical judgment in making decisions and recommendations.
  • Adheres to Company policies, CGMPs and applicable Standard Operating Procedures when performing job responsibilities and assigned tasks.
  • Effectively manages workload and prioritizes work in line with the overall department and Company objectives and requirements.
  • Adheres to schedules, provides timely reports/assessments and ensures appropriate corrective and preventative actions are identified and implemented in a reasonable timeframe.
  • Ensure training programs are meaningful and effective and addresses the company needs.
  • Maintains complete and accurate documentation/records/data (electronic or paper), filed in an organized and easily retrievable manner
  • Communicates well and conducts oneself in a professional manner both inside and outside the Company.
  • Provides routine progress reports and keeps QA management informed of on-going activities.
  • Ensures electronic information systems/databases are both effective and efficient and support the needs of the department and company.
  • Works on continual Quality system improvements and efficiencies, developing new systems and/or modifications to existing ones, as required.
  • Provides routine progress reports and keeps management informed of on-going activities.
  • Works independently or as part of team, forsters a positivie work environment and provides support, guidance and functional direction to other departmental employees in area of responsibility.

 

Job Responsibilities:

  • Co-ordinates the process, cleaning and computer system validation programs, which includes
    • Executin of the Master Validation Plan by scheduling and coordinating the preparation and execution of the protocols, based on current production schedules. Depending on company needs, more focus may be applied to one or more projects at time.
    • Mnitoring the progress of activities supporting the validation studies, compiling and preparing reports and maintaining summaries and indexes as required.
  • Provides guidance on validation relate matters and acts as a validation representative on interdepartmental teams as assigned and may also take on the role of project leader, where applicable.
  • Reviews and approves protocols and reports relating to the qualification of equipment, systems (such as utilities/computer) & facilities (DQ, IQ, OQ, PQ) and acts as a team member to provide regulatory guidance on ongoing projects, where applicable.
  • Assesses and approves devitaions/non conformances, trend data and proposed changes to processes (i.e., MBR changes), systems, equipment and facilities for impact on the validated status and provides recommendations for revalidation where necessary.
  • Prepares validation data summaries for Annual Product Reviews asa well as other reports etc.
  • Reviews and approves documents, procedures, reports, certificates, etc., in accordance with SOPs and GMP standards for active pharmaceutical ingredients.
  • Contributes to the development of effective projects by assessing priorities, evaluating the various typs of documents required and ensuring appropriate training is provided and acts as project leader as assigned by management.
  • Reviews current and proposed regulatory guidelines and regulations and prepares summary and impact analysis reports for management review. As necessary, develops and acts implementation plans.
  • Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities;
  • Works as a member of a team to achieve all outcomes;
  • Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
  • Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion and
  • All other relevant duties as assigned.

 

Job Requirements:

  • Education
    • Educatin at the University, or equivalent level in a related scientific discipline
  • Knowledge, Skills and Abilities
    • Practical validatin experience and understanding of GMP regulations related to manufacturing equipment qualification and validation (process, cleaning and computer system) requirements in Canada, USA and International (ICH)
    • Effective and skilled cmmunication (verbal and written) including good report writing, organizational and project management sklls.
    • Prficiency in computer applications and programs such as Word, Excel and Project Management related software
  • Experience
    • Minimum 2 years related experience in the Pharamceutical Industry (or GAMP industry). 

 

 

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
 
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

 

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