Apollo Health & Beauty Care (Apollo) is a premium developer of private label and control label health & beauty care products and leverages unique expertise and experience in developing national brand-equivalent products designed to compete equivalently with the most popular national brands. The largest private label and control label personal care manufacturer in Canada, Apollo has formidable penetration and distribution in the North American marketplace and also services customers throughout Central and South Asia, Mexico, Europe and Asia. Building on our core values of Excellence and Commitment, Apollo has established itself as a market leader that attracts the industry's top talent. We are currently searching for an energetic, motivated Validation Coordinator to join our Quality Team!

POSITION SCOPE:

The Validation Coordinator participates in the completion of milestones associated with specific projects and supports ongoing validation efforts and quality systems responsibilities in support of the manufacture, testing, and release of formulated drug substance. This role contributes to the development of concepts and techniques specific to validation and risk management and completes tasks in a creative and effective way. The Validation Coordinator serves as the quality contact for quality projects and continuous improvement efforts regarding Validation and Quality Risk Management.

RESPONSIBILITIES & DUTIES:

Provides oversight for the commissioning and qualification of new equipment, instruments, including major capital projects and computer systems.

Maintains and enhances validation programs for existing equipment, utility commissioning and qualification, and computer systems.

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, method, computer, 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.

Manages validation contractors as required.

Ensures the site Validation Master Plan remains current and aligned with corporate policies and industry standards/expectations.

Develops and implements statistical tools for Quality Systems monitoring and review.

Reviews and approves changes to critical processes, facilities, equipment and systems through the change control program to assess impact on validated systems.

Represents the Validation Program for Quality Assurance Department in customer / regulatory audits and responding to audit observations and corrective actions.

Identifies and implements improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes.

Collaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, Facilities, and Regulatory Affairs.

Provides technical assistance and training for personnel.

Files and maintains controlled documents.

Other duties as assigned.

Qualifications:

5 years of GMP-related experience in biopharmaceutical or pharmaceutical or pharmaceutical manufacturing facilities

B.S. degree in Chemistry, Biology, Engineering or related field

Thorough knowledge of cGMP/GDP and international regulatory requirements

Operations experience in a GMP environment

Ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment

Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Duties outlined on this job description may not be all-inclusive, and can be modified at any time if requested by management. Apollo is committed to providing accommodations for people with disabilities in all parts of the hiring process. Apollo will work with applicants to meet accommodation needs that are made known in advance.

We thank all applicants for their interest however only those meeting the minimum qualifications will be interviewed.