Validation Coordinator

Apollo Health And Beauty Care•Toronto, ON

4d•CA$65,000 - CA$70,000

About The Position

The Validation Coordinator helps to implement the validation strategy, executes the activities and completes the milestones associated with specific validation/qualification projects. This role supports ongoing validation efforts and quality systems responsibilities in support of the manufacture and testing of formulated drug products. This individual contributes to the development of concepts and techniques specific to validation strategies and risk management assessments. The Validation Coordinator participates in the completion of tasks in a creative and pragmatic effective way. This position serves as one of the quality resources for identified projects that support continuous process improvement efforts regarding Validation and Quality Risk Management.

Requirements

Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, Chemistry, Microbiology, or a related field.
Minimum 3–5 years of experience in Validation, Quality Assurance, and Quality Control within pharmaceutical or biopharmaceutical manufacturing environments.
Working knowledge of cGMP, GDP, ICH, Health Canada, FDA, and other applicable regulatory requirements.
Experience working in regulated manufacturing settings with a focus on quality and compliance.
Ability to interpret and apply regulatory standards and industry best practices.

Nice To Haves

Experience with equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, utility qualification, and computerized systems validation is considered an asset.

Responsibilities

Performs commissioning and qualification of new and existing production equipment and instruments, including major capital projects under the guidance of Validation Manager/VP of Quality.
Maintains and enhances validation programs for existing equipment, utility commissioning and qualification.
Participates in optimization of existing process validation procedures and technical transfer activities, including assessments of Critical Quality Attributes and identification and analysis of Critical Process Parameters.
Assists in the development of a process validation program including assessments of Critical Quality Attributes and Critical Process Parameters.
Drafts, reviews, executes and approves protocols and reports related to equipment, facility, and process validation. This includes deviation reporting during execution.
Acts as Quality contact and primary Subject Matter Expert (SME) for Validation and Quality Risk Management.
Under the guidance of Validation Manager/VP of Quality evaluates and updates the Validation Master Plan making sure that it remains current and aligned with corporate policies and industry standards/expectations. Ensures, the validation activities are performed as per Validation plan and meets the timelines.
Provides guidance and leads Validation Associate’s and Validation Assistant’s.
As a member of validation team is involved in regulatory audits and responses to audit observations and corrective actions.
Works together with validation group analyzing and implementing improvement opportunities for established quality systems, validation processes, and technical transfer procedures.
Understands and supports current industry practices for CAPA, Change Control, Deviation, Risk Management, and Investigation processes and procedures.
Collaborates with cross functional groups, including Quality, Manufacturing, Process Development, Engineering, and Regulatory Affairs.
Files and maintains controlled documents.
Provides technical assistance and training for personnel.
Exhibits a good working knowledge of current GMP, ICH, Health Canada and FDA guidelines and regulations related to quality systems and validation procedures that are being updated for the new industry trends and upcoming changes.
Perform other duties as assigned.