Quality Assurance Manager

Toronto, ON, Canada

Job Description


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 by HPFBI and the FDA; Bachelor Degree or higher in Chemistry or Microbiology required with other certifications beneficial. Interpersonal Skills/Contacts: Regular access to confidential or sensitive information; frequent and regular internal interactions and frequent external interactions; purpose of internal/external contacts is regularly related to complex matters and may have high levels of consequence and costs associated with errors; occasional selling, negotiating, consulting, teaching/instructing, or advising; above average level of written and verbal communication skills required for successful job performance. Problem Solving/Judgment: Position has significant amount of autonomy in terms of level of monitoring and decisions generally do not follow prescribed guidelines; regular and frequent analysis required; regularly and frequently makes recommendations or referrals; responsible for frequently solving complex technical problems or personnel issues. Mental Effort: Requires high levels of concentration and/or attentiveness; sustained duration and/or intensity of efforts; requires high levels of thinking, watching, listening, verifying, checking numbers, creating or designing. Physical Effort: Occasional duration or intensity of physical effort; moderate energy required in terms of standing, walking, lifting, keyboarding, pushing, pulling, sitting, packing, assembling, bending or twisting; includes moderate fine or coarse movements. Material Resources: High level of consequence and costs associated with errors as related to losses of time, money, or property; high responsibility for significant machinery, work aids, equipment, materials, properties, products, stock, inventory or tools. Information Resources: High level of consequence and costs associated with errors as related to losses of time, money or property; moderate responsibility for information and or services; regular access to confidential, sensitive or proprietary information. People/Policies/Practices: Management responsibility for people, policies or practices in terms of assigning work, development, evaluation, supervision, health and safety, performance, scheduling of work, training, coaching, or well being; regularly demonstrates work practices to others or is required to influence others to achieve output goals; overall responsibility for departmental output. Financial Resources: Regular responsibility for financial data, money or financial transactions, budget management financial records, expenditures, acquisition, financial analysis or risk management; regular opportunity to cause a negative impact to the organization or cause a serious consequence as a result of an error. Environment: Works in an office environment within a manufacturing environment with regular or some exposure to dirt, dust, grease, oil, noise or temperature extremes; frequently faces multiple demands or distractions; has limited exposure to poor ventilation. Hazards: Average to moderate exposure to chemicals, fumes or smoke; has occasional to regular potential of injury, harm, illness or infectious disease; has occasional to regular exposure to machinery or equipment; may require occasional local or overnight travel. \xe2\x80\x9cAPOLLO Health & Beauty Care will ensure accommodations are available in consultation with candidates during all stages of the recruitment process\xe2\x80\x9d

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.

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Job Detail

  • Job Id
    JD2107631
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Toronto, ON, Canada
  • Education
    Not mentioned