Validation Associate

3 weeks 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 Validation Associate to join our Team
POSITION SUMMARY:
The Validation Associate 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 Assistant 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.
RESPONSIBILITIES & DUTIES:
  • Performs commissioning and qualification of new and existing production equipment and instruments, including major capital projects under the guidance of validation specialist and coordinator.
  • 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 cleaning validation program.
  • Drafts, reviews, executes and approves protocols and reports related equipment, facility, and process validation. This includes deviation reporting during execution.
  • Executes validation/qualification protocols and reports related to equipment, process validation and technical transfer of the manufacturing processes from development and research departments to production.  
  • Under the guidance of validation coordinator evaluates and updates the Validation Master Plan making sure that it remains current and aligned with corporate policies and industry standards/expectations.
  • 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.
  • 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.
  • Other duties as assigned.
JOB SPECIFICATIONS:
KNOWLEDGE/EDUCATION/EXPERIENCE: 2-3 years of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing facilities. University degree in science, engineering or related field; Good knowledge of cGMP/GDP and international regulatory requirements.
INTERPERSONAL SKILLS/CONTACTS: regular access to confidential or sensitive information; purpose of internal/external contacts regularly related to complex matters; regular selling, negotiating, consulting, teaching/instructing, or advising; average level of written and verbal communication skills required.
PROBLEM SOLVING/JUDGMENT: position has some autonomy in terms of level of monitoring and decisions usually do not follow prescribed guidelines; regular analysis required; regularly makes recommendations or referrals; responsible for solving moderate problems
MENTAL EFFORT: requires moderate to high levels of concentration.
PHYSICAL EFFORT: occasional duration or intensity of physical effort; some moderate energy required.
MATERIAL RESOURCES: moderate to high level of consequence and costs associated with errors as related to losses of time, money, or property; moderate responsibility for machinery, work aids, equipment, materials, properties, products, stock, inventory or tools.
INFORMATION RESOURCES: moderate to high level of consequence and costs associated with errors as related to losses of time, money or property; moderate to high responsibility for information and or services; regular access to confidential, sensitive or proprietary information
FINANCIAL RESOURCES: occasional responsibility for financial data, money or financial transactions, financial records, expenditures, acquisition, financial analysis or risk management; has moderate to high opportunity to cause a negative impact to the organization or cause a serious consequence as a result of an error.
ENVIRONMENT: works in an environment with occasional or some exposure to dirt, dust, grease, oil, or temperature extremes; may frequently face multiple demands or distractions; has limited or no exposure to poor ventilation, noise, or verbal abuse
HAZARDS: limited or occasional exposure to chemicals, fumes or smoke; has little or unlikely potential of injury, harm, illness or infectious disease; has limited or some exposure to machinery or equipment; may require occasional local travel
 
“Apollo Health & Beauty Care Ltd. will ensure accommodations are available in consultation with candidates during all stages of the recruitment process”
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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