Validation Coordinator

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 Coordinator _**_to join our Team_

**POSITION SCOPE**:
The Validation Coordinator 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 Coordinator 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 Manager/VP of Quality.
- Maintains and enhances validation programs for existing equipment, utility commissioning and qualification.
- 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 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, 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.
- Under the guidance of Validation Manager/VP of Quality 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.
- Provides technical assistance and training for personnel.
- 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.

**JOB SPECIFICATIONS**:
**KNOWLEDGE/EDUCATION/EXPERIENCE**: 3 to 5 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 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,

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