Quality Compliance Manager (Pharma)

Quality Compliance Manager (Pharma)

Industry: BioPharmaceutical

Salary : Up to $12,000 depending on experience

Job Purpose:

The Quality Manager performs the function as the Regional Quality Officer (RQO) for the Asia South and Singapore/Malaysia Affiliate Operations

Included in these responsibilities is the day-to-day support of the quality activities within the Asia South and Singapore/Malaysia Affiliate are:

• Maintenance of the CSL Behring Quality System and ensure compliance with all CSL Behring requirements for the affiliate operations.

• Receipt and processing of product technical complaints, and support investigations including counterfeit product investigations.
• Provide Quality oversight in support of Warehousing & Logistics, and Customer Service activities.
• Ensure timely final administrative release for products or support local batch release enquiries for respective markets.Manage deviations impacting the release of material and work to resolve issues to limit market impact.
• Serve as a real-time support and interface function for Commercial Operations, Global Logistics and all Sites of Manufacture.
• Act as Recall Coordinator for the Affiliate
• Collaborates with External Supplier Quality Assurance (ESQA) function to ensure that the established audit program is implemented.
• Ensure Quality Agreements between the Affiliate and distributors are in place.
• Management of SOP and training system.
• Review and evaluates new or changes to local GMP/GDP Regulations and assesses impact to current business practices.
• Drive continuous improvement and efficiency initiatives in Quality operations
• Act as Quality Deputy for Korea Affiliate.

Responsibilities:

• Responsibilities and Accountabilities: List the roles and responsibilities of the position (please limit the number of responsibilities to the primary ten.)

• Supports the investigation and reporting of Product Complaints originating in Asia South & Singapore according to the CSL global procedures. Ensures CAPAs resulting in Complaints investigations are implemented.
• Serves as the main point of contact for oversight and management for Asia South & Singapore distributors. SupportsLogistics deviation investigations including deviations within CSL Supply chain and Complaints as required. Actions will include organizing SQuIPP review assessments, issuing notice to quarantine product and oversight of the end-to-end deviation process impacting the Asia South & Singapore Market.
• Final administrative release for products or support local batch release enquiries for respective markets within the appropriate systems (SAP) where applicable and associated processes. Liaison with manufacturing site Qualified Persons and batch release personnel as necessary.
• Collaborates with Customer Service, Medical Information and Global Logistics Operations to promptly resolve customer inquiries relevant to product quality and possible temperature/storage concerns following release of product from supply chain.
• Act as Affiliate Recall Coordinator for recalls impacting the Asia South & Singapore markets. Lead or support all affiliate recall, market withdrawal and/or field action actions and ensure they are completed and communicated to key stakeholders within the organization.
• Supports investigation of reports of counterfeit product discovered in Asia South & Singapore. Liaise with required functions (eg. Logistics, Customer Service) to provide batch number verification through electronic systems for customer complaints or inquiries as required.
• Supports maintenance and management of Quality Agreements between Asia South & Singapore distributors. Also maintain Quality Agreements between the Asia South & Singapore Affiliate and all Sites of Manufactures.
• Establish and maintain a GxP training program in Asia South & Singapore for functions requiring GxP training.
• Communicate changes to Asia South & Singapore distributed products to all impacted business functions (Commercial Operations, Global Logistics, etc.).
• Create and manage Quality Management System for the Asia South & Singapore Affiliate which includes Policies, SOPs and Work Instructions.
• Review and evaluate new regulations or changes to local GMP/GDP Regulations and assesses impact to current business practices.Communicates requirements to impacted parties in a timely manner.
• Produce documentation for global inspections when requested in a timely manner. Work with multiple groups to acquire the requested documentation as needed.
• Maintain the Asia South & Singapore Inspection readiness program and risk register.
• Execute Quality Management Review for the AsiaSouth & Singapore affiliate
  
  
  Requirements:

• Requires a bachelor’s degree in a relevant business or science discipline.
• Requires minimum of 5 years’ experience as a GMP quality or systems professional in pharmaceutical manufacturing of drug products, medical devices or related field.
• Experience with Good Distribution Practices(GDP) systems implementation and utilization is desirable. Requires effective communication, collaborative and negotiation skills.
• Comfortable working in a global, matrix organization.
• This role requires limited travel.

Lim Pey Chyi - [email protected]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423