Validation Specialist - #380770

Location: Mississauga, ON
Date Posted: 4/17/2024
Job Number: JO-2404-1690

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: Validation Specialist
DEPARTMENT: Innovation, Development and Transfer Services
POSITION REPORTING TO: Technical Operations Manager

General Description
Responsible for Process Validation of the manufacturing and packaging processes for Solid Dose, Liquid and Semi Solid Dosage forms, and support investigations

Responsibilities:

• Conduct validation reviews and prepare Process Validation Summary reports
• Prepare, review, and execute Performance Qualifications (PQs) protocols, Bulk Hold protocols, validation/bulk hold summary reports and validation master plans
• Assess changes in process, API, Raw materials or components for their impact on process validation
• Perform internal seif inspections of the technical area and ensure compliance with internal and Regulatory standards
• Respond to process validation queries from Regulatory authorities and clients in a timely manner
• QMS documents pertaining to the area of responsibility are reviewed and risks evaluated in a timely manner
• Uses product and process knowledge as the basis for risk-based validation and continuous verification programs
• Participate in investigation for deviations and product incidents that impact validation. Review investigations related to validation and help identify root cause and assign and/or complete appropriate CAPAs.
• Interpret and apply QMS and regulatory requirements, updating procedures as required.

Qualifications:
Experience and Skills

• Minimum 3-5 years of pharmaceutical experience
• Knowledge of GMP, Quality Control, Quality Assurance, Production or Engineering
• Good understanding of the principles of process validation
• Able to make informed decisions on validation approach and requirements
• Demonstrate ability to participate in constrained projects with exact timelines.
• Strong technical writing skills and attention to detail.
• Strong interpersonal and communication skills.

Education
Required:

• Bachelor’s Degree in science or related field or equivalent on the job experience 2+ years of service.

Preferred:

• Additional knowledge of the Pharmaceutical manufacturing and packaging industry or other regulated industry

WORKING CONDITIONS
Mainly office environment with regular visits to production area. Require the use of PPE to prevent exposure to hazardous materials when in production area

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