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Operational Quality Specialist
Mississauga, ON
4/23/2024
JO-2309-1654

Bora Pharmaceuticals is focused on developing and manufacturing branded, generic and over the counter (OTC) healthcare and pharmaceutical products for patients around the globe. At Bora Pharmaceuticals, we see it as our mission and our duty to make our mutual success more certain. As an ambitious, future-focused company, we know better than most that our own success is shaped by our partners victories. At Bora, we insist on high quality, reliability, and efficiency without any compromises. Dedication to these high standards is how we create a long-lasting company culture that is the bedrock for our growth.

We cover the entire pharmaceutical supply chain from research and development to sales and distribution. We focus on manufacturing and selling generic, brand, and over-the-counter (OTC) drugs to clients around the world.

Why join Bora?

  • Competitive salary and generous annual bonus
  • 3 weeks vacations + paid personal and sick days
  • Extended Health Care and Dental Benefits Programs
  • Defined Contribution Pension Plans (DCPP) matched up to 4%
  • On-site gym and basketball court
  • Tuition reimbursement programs
Click here for a video tour of our Mississauga facility: https://lnkd.in/evhPktDN

POSITION DESCRIPTION
 
TITLE: Operational Quality Specialist(change control focus)
DEPARTMENT: Quality
POSITION REPORTING TO: Quality Manager/Supervisor

General Description
Operational Quality Specialists (OQS) ensure Bora’s products and processes meet established quality standards. They provide quality support to a myriad of areas such as deviations, complaints, validation, review and release. Their key responsibilities are listed but not limited to the following.

Responsibilities
  • Prepare and implement quality assurance procedures (such as SOPs) and be responsible for reviewing as required.
  • Participate in investigation of complaints, deviations, and product incidents (API & Finished product related) ensuring that all investigations are thorough, complete, identify root cause, and assign appropriate CAPAs.
  • Review batch records and associated documentation, releasing or rejecting batches as per quality procedure.
  • Participate in improvement projects for Quality systems and other special projects and initiatives, including new product introductions, significant changes to equipment/systems, etc.
  • Coordinate planned changes initiated by various business units, suppliers, as well as customers and ensure relevant quality procedures are followed.
  • Author and review Periodic Product Reviews and assign actions as required.
  • Coordinate responses to internal improvement documents as required, such as audit observations, ensuring compliance to recommendations.
  • Accountable for team and site metrics.
  • Participate in inspections including roles such as hosting, mission control, auditor, auditee, etc.
Qualifications
Experience and Skills
  • OQS - 2-5 years (Variable based on role requirement)
Education
Required:
  •  Bachelors degree in Science for Batch release position   or related field or equivalent on-the-job experience through years of service
  • College program completion for OQS role
  • Science or engineering, preferably, in order to understand the science behind technical aspects of product performance and to be able to make informed decisions and release Product to market as per GMPs. 
Preferred:
  • Experience in Operational Quality Assurance or related role with similar responsibilities; Minimum 2 years in Pharma industry.
  • Adequate knowledge of regulatory framework and demonstrated ability to make informed decisions.
  • Demonstrated ability to participate in projects or change initiatives with the ability to make sound quality decisions.
  • Strong interpersonal and communication skills.
  • Excellent technical report writing and reviewing skills. 

Bora is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities.  Bora is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at accessibility@bora-corp.com.  Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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