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Validation Specialist

Apollo Health And Beauty Care

Validation Specialist

National
Full Time
Paid
  • Responsibilities

    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 Specialist to join our Quality Team!

    POSITION SCOPE:

    The Validation Specialist implements 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 Specialist leads 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:

    Directs and provides oversight for the commissioning and qualification of new and existing production equipment and instruments, including major capital projects.

    Develops new and optimizes existing process validation procedures and technical transfer activities, including assessments of Critical Quality Attributes and identification and analysis of Critical Process Parameters.

    Drafts, reviews and 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.

    Is one of the quality contacts and primary Subject Matter Experts (SME) for Validation and Quality Risk Management.

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

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

    Identifies and implements 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.

    Provides technical assistance and training for personnel.

    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: 5+ years of GMP-related experience in biopharmaceutical 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 prioritiz441053.087737e 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.

    INTERPERSONAL SKILLS/CONTACTS: regular access to confidential or sensitive information; frequent internal interactions and/or regular to frequent external interactions; purpose of internal/external contacts regularly related to complex matters; regular 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 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 and/or attentiveness; moderate duration and/or intensity of efforts; requires higher levels of thinking, watching, listening, verifying, checking numbers, creating or designing

    PHYSICAL EFFORT: occasional duration or intensity of physical effort; some 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: 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

    PEOPLE/POLICIES/PRACTICES: 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; may occasionally demonstrate work practices to others

    FINANCIAL RESOURCES: occasional to regular 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.