Quality Assurance Validation Project Leader

Job Summary

Responsible for managing and ensuring the compliance of projects related to Process Validation (including Sterile/Aseptic Process Validation), Cleaning Validation and Equipment and Facility Qualifications. Accountable for communicating status of these validation projects to the management group.  Responsible for the review and approval of proposed validation documentation and strategies which ensure the validation program remains compliant with the TPD, FDA, EU, Apotex SOPs and other regulatory guidelines. Responsible for providing guidance and acting as a resource with knowledge pertaining to the regulatory requirements of the Validation requirements for various departments such as R&D Formulation Development, Engineering, Technical Operations, Production, Regulatory Affairs and other subsidiary groups within Quality.

Job Responsibilities

• Reviews the Validation Master Plans for compliance with regulatory requirements.
• Reviews validation strategies and associated documentation against the requirements of the Validation Master Plan, to ensure that compliance and business needs are achieved. 
• Acts as QA reviewer/approver/responsible on:
• Process Validation related protocols, reports and other documents.
• Commissioning documents, SATs, FATs, qualification protocols and reports, Equipment & Facility Change Controls,
• Preventative Maintenance & Calibration orders, assessment and approvals as required.
• Calibration/Facility related failure Investigation
• Cleaning Validation related protocols, reports and other documents.
• Technical Operations related protocols and reports (Demonstration, Technical Transfer).

• Works closely with the Process Validation, Equipment & Facility Qualification, Cleaning Validation and Technical Operation groups to provide support and guidance to our customers (e.g. Production, Facilities, Packaging, Engineering, Formulation Development), in problem solving and troubleshooting of validation issues and suggest CAPAs as required.

• Performs technical assessments using the appropriate change control procedures (e.g. QMS Trackwise) and acts as QA approver where required.
• Act as QA SME for reviews/approvals of proposed remedial and corrective actions related to deviation investigation and other excursions related to out of trend/specification of validation/qualification data, as required. 
• Acts as a member of teams and/or committees such as new product launch, Change Control Board to provide guidance related to validation regulations/guidelines.

• Participate in periodic reviews of Preventative Maintenance and Calibration trends.
• Via review/approval of Process Validation Protocols and Reports, ensures that manufacturing/packaging processes are maintained in a validated state of control. Provides notification of discrepancies and/or concerns to the applicable departmental manager.
• As applicable, reviews change controls for procedural changes. Reviews and approves impact of changes according to the applicable change control procedures (e.g., QMS Trackwise).

• Ensures that all work is performed in full compliance with Good Manufacturing Practices and Standard Operating Documents/procedures.

• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
• Minimum B.Sc. / B.Eng (in related field) degree or equivalent.
• Knowledge, Skills and Abilities
• Experience in a liquid dosage manufacturing environment, with a strong understanding of TPD, FDA, EU and other applicable regulatory guidelines related to Validation.
• Demonstrated high level of knowledge, skill, or expertise in validation concepts, with experience using statistical tools for evaluation of process capability and control.
• Proven organizational, time management, and project management skills.
• Knowledgeable user of SAP and TrackWise systems.
• Ability to analyze systems and processes and recommend process improvement.
• Excellent problem solving and troubleshooting abilities.
• Excellent oral and written communications.
• Strong interpersonal skills.
• Demonstrated ability to work effectively as a team member with employees at all levels of the organization.
• Ability to work independently with minimal supervision.
• Strong customer service orientation.
• Working knowledge in the use of Microsoft office tools or similar software.
• Experience
• 5+ years of pharmaceutical manufacturing experience, a minimum of 4 years within a technical Validation role.