Quality Assurance Manager

1 month ago

Toronto, Canada Apollo Health And Beauty Care Full time

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 _
**_Quality Assurance Manager _**:

- to join our Team_

**POSITION SCOPE**: The Quality Assurance/ Quality Control Manager has process-oriented responsibility and oversight for the Quality Management System focused on compliance to applicable regulations including but not limited to FDA and Health Canada for OTC, NHP and Cosmetic products. Direct responsibility for QMS, batch release, Quality Control Laboratory, deviation, resolution, correction and prevention; with focus on continuous improvement, right the first time and on time delivery.

**RESPONSIBILITIES & DUTIES**:

- Batch Release: Manages approvals for raw material, bulk and finished product release, rejection and quarantine.
- First Time Quality: Actively monitors production lines and product launches to ensure first time quality is achieved by auditing finished product for conformity to prescribed standards based on audit samples pulled from the Production Lines; generate compliance and non-compliance/variance reports inclusive of root cause analysis, risk analysis based on aspects introduced to the manufacturing process, and recommendations for corrective actions.
- Deviations / OOS: Approves all plant, manufacturing deviations, laboratory OOS / deviations and subsequent CAPA and effectiveness check.
- Documentation: Oversees and develops specifications for incoming raw material and finished goods, and protocols for validation / qualification of test methods to comply with compendium.
- Continuous Improvement: Supports identification of issues and concerns regarding Quality Assurance and Control. Supports Quality and Compliance projects, in addition to initiatives and new business opportunities.
- Investigations: Investigates and document issues that may affect product quality or productivity, generate corrective actions and oversee implementation.
- Internal Compliance: Audit internal processes and the manufacturing floor level for compliance to standards and reporting on compliance status.
- Training: Develops training as an outcome or extension of SOPs; Conduct GMP training at the operator level on the manufacturing floor and act as a mentor to ensure understanding of and adherence to SOPs, GMPs and GDPs.
- Inspection: Oversees inbound receipt of components ensuring inspection, compliance and release for use in a timely manner.
- Reconciliation: Manages and reviews the preparation and support storage of all batch records and ensuring all paperwork generated at the manufacturing level complies with GDP requirements.
- Quality Control Laboratory: Manages all Quality control laboratory functions including oversight of equipment and testing to ensure conformance of each formulation to its approved specifications through raw material/bulk/finished goods and microbiology testing.
- SME: Acts as business partner and resource to production on manufacturing, filling, packaging and quality related matters.
- People: Management responsibility for direct reports including hiring, disciplinary actions including termination of employment, training, health & safety, scheduling of work. Provide coaching and guidance to team members on daily activities. Support an environment that promotes communication at all levels and strives to make all information available when and where needed. Support to develop a culture that promotes troubleshooting and problem solving at the supervisor/team lead and employee level.
- Supervision: A) Quality Assurance Supervisors; B) Quality Control Laboratory Supervisor(s)
- Health & Safety: Ensuring all due diligence requirements and obligations under S.27 of the Occupational Health & Safety Act and all Company Standards, Policies, and Procedures are met and where possible exceeded; provide support and assistance to the Joint Health & Safety Committee in compliance with the JHSC Terms of Reference HSS.006
- Other: Perform other duties as assigned

**JOB SPECIFICATIONS**:
**Knowledge/Education/Experience**:10+ years progressive experience in a pharmaceutical manufacturing, packaging and testing environment; extensive experience in QC laboratory operations and Quality Assurance functions related to manufacturing controls and change control management; expertise in GMP / cGMP guidelines as set b

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