Job Summary: Responsible for providing QA general support for assigned TPM’s and/or Suppliers and QA due diligence for Licensing and Acquisition playbook deal that fall under APAC and China to ensure that safe, efficacious, and quality product can be supplied to APAC and China region to meet cGMP and other applicable regulatory standards and the appropriate market requirements
Main Responsibilities: Responsible for ensuring that QA due diligence for Licensing and Acquisition playbook deals, TPM’s and/or suppliers maintain compliance with the Quality Agreements and local and International regulations as required by markets supplied and ensuring that the quality systems are appropriate so that the product safety, efficacy and quality are maintained.
Job Scope:
· Manage TPM’s and/or Suppliers as assigned from a Quality perspective.
· Manage all Quality System activities associated with the role for the management of suppliers and /or TPMs, including:
o Develop and maintain Quality/Technical Agreements to align with legal contracts and regulatory requirements.
o Management of high impact exception events and CAPA ensuring events are appropriately assessed for impact to company and documented.
o Review and approval of TPM Product Quality Reviews to ensure accuracy and completeness and management of actions to address any identified trends.
o Review and approval of complaints arising from TPM/Supplier manufactured product and follow-up on complaint trend investigations for non-medical and medical (adverse events) complaints.
o Management of all changes at TPMs/Suppliers which have a quality or regulatory impact, ensuring timely communication & implementation of changes in line with regulatory requirements.
o Maintain a Quality Management Review program and Quality Performance Measurement for assigned TPMs / Suppliers, that identify and address quality, operational, and organizational issues.
o Maintain a Quality Management Review program and Quality Performance Measurement for assigned TPMs / Suppliers, that identify and address quality, operational, and organizational issues.
o Participate on QA cross-functional teams to support TPMs, including active participation in Business Management Reviews or Workstreams, as necessary.
o Visit TPMs and/or supplier locations routinely to build and maintain expertise with products and manufacturing processes building a close working relation with the TPM &/or supplier
o Provide support to management through the Significant Event and Management Review process to ensure relevant information is provided for events impacting assigned TPM/Suppliers.
o Support a program/project management process to support quality and compliance improvement initiatives at TPMs and/or Suppliers.
o Provide support to quality audits, initial site approvals.
o To perform projects and tasks as assigned.
· Participate in projects assigned as due diligence for all APAC and China regional product in-licensing, acquisition deal or distribution deal if applicable, including:
o Perform due diligence (DD) audits for new playbook deals through on-site audits/desktop audits for the third-party manufacturer included the subcontractor and contract laboratories for initial selection and qualification in accordance to regulatory and business requirements. Compile the DD audit reports/elevation slides to summarize the risks associated with potential partners.
o Support in establishing and implementing due diligence processes and procedures for the application into the quality & technical assessment of medical products, medical device and consumer health products for new business opportunities.
o Assess the appropriateness and timeliness of proposed CAPAs for DD audits, and track CAPA follow up to close for initial audits. Ensure a proactive determination of regulatory, compliance and quality issues and integrate them into audits/assessments on a priority basis.
o Provide support to regional quality system for supplier and TPMs routine audit as per request
Requirements:
· Bachelor’s degree or equivalent level of education at a relevant scientific discipline or other technical/scientific, or industry experience with sufficient exposure to pharmaceutical or related industries
· Total combined years: 10+ in QA, Operations or Pharmaceutical engineering
· Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations
· Knowledge of international and local quality system and compliance legislations and standards
· Leadership experience
· TPM and supplier relationship building experience
Additional Information:
· Contract duration: 12 to 24-month contract
· Commencement Date: Immediate
· Working days and hours: Mon to Friday, 9am to 6pm
· Location: Duo Tower, Bugis MRT
