Operational Quality Specialist

Bora Pharmaceuticals is a global leader in the development and manufacturing of branded, generic, and over the counter (OTC) healthcare and pharmaceutical products. Our mission is to ensure the mutual success of our partners by maintaining high standards of quality, reliability, and efficiency. At Bora, we believe that our own success is intertwined with that of our partners, driving us to consistently deliver exceptional results.

Our comprehensive pharmaceutical supply chain covers research and development, sales, and distribution. We focus on producing and marketing generic, branded, and OTC drugs to clients worldwide, with a dedication to meeting diverse healthcare needs.

Why join Bora?

• Competitive salary
• A modern and state-of-the-art facility
• An on-site cafeteria with dedicated chefs
• On-site gym and basketball court

Click here for a video tour of our Mississauga facility: https://lnkd.in/evhPktDN

POSITION DESCRIPTION

Job Title: Operational Quality Specialist

Employment Type: Fulltime Permanent

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, change control, complaints, periodic product reviews, 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 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)
• Experience in new product introduction (NPI), early development and clinical trial submissions will be a strong asset.
• Strong communication skills are a must as this role requires interfacing with clients

Education

Required:

• Bachelor’s 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 [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.