Validation Specialist - Mississauga, Canada - Bora Pharmaceutical Services

Bora Pharmaceutical Services

Verified Company

Mississauga, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Location:

Mississauga, ON
Date Posted:
4/17/2024
Job Number:
JO 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, futurefocused 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 longlasting 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 overthecounter (OTC) drugs to clients around the world.

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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%
Onsite gym and basketball court
Tuition reimbursement programs
TITLE: Validation Specialist

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DEPARTMENT:Innovation, Development and Transfer Services
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POSITION REPORTING TO: Technical Operations Manager
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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 riskbased 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.

Qualifications:

Experience and Skills_
Minimum 35 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.