Manager Pharmaceutical Process Validation - Windsor, Canada - BioVectra Inc.

BioVectra Inc.

Verified Company

Windsor, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Manager Pharmaceutical Process Validation
Windsor, NS, Canada Req #1104
Monday, February 6, 2023

BIOVECTRA Inc.

is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.

BIOVECTRA has an opening for a
Manager Pharmaceutical Process Validation This is a
permanent, full-time position
located in Windsor, NS**.

Establishing the tech transfer, scale up, and validation strategy for new processes/equipment and translates those requirements to appropriate validation protocols and standard operating procedures.
Working with the Process Development Group to ensure appropriate critical process parameters are implemented, justified, and measured to control the process critical quality attributes.
Identifying potential scale up obstacles and working with Engineers, Quality Assurance, Process Development and Manufacturing professionals to ensure validation risks are mitigated and controlled.
Leading participant in conducting process risks analysis and process hazard analysis.
Developing, maintaining, and updating the Validation Master Plan (VPM) for the overall project.
Qualification of new equipment/processes, computerrelated system qualification and calibration program management.
Reviewing detailed plant layouts, procedures, and equipment specifications (URS) to ensure the project progress and quality / regulatory compliance.
Conducting and/or participating in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA), maintaining compliance within the company.
Communicating and reporting the status of each project to the management and department that sponsors the project.
Working as part of a multidisciplinary team.
Reviewing and updating Standard Operating Procedures to ensure appropriate content.
Ensuring employee's training is performed and maintained.
Coaching and conducting performance reviews from the team.
Ensuring that the Validation department meets budget provided by Senior Management.
Providing technical expertise and oversight on various technical documents (BPR's, New Product Validation Reports, etc.).
Developing staff regarding teamwork, validation techniques and procedures to ensure cGMP compliance.
Managing multiple complex technology transfer projects related to the manufacturing and testing.
Authoring and reviewing technical documents including standard operating procedures, testing protocols, technical reports, batch files and technical transfer documents.
Bachelor of Science in Chemistry, Biochemistry, Bioengineering, Chemical Engineering, or related field.
Five years pharmaceutical industry experience.
Statistical analysis tools and methods.

**Closing Date: April 28, 2023