Objective(s):

To maintain and continuously improve the affiliate quality system in compliance with Roche Pharmaceutical Quality System requirements, local GxP-regulations and applicable ISO-standards whilst ensuring an uninterrupted supply of quality products to patients.

Key Responsibilities

• To conduct regular management review of the QMS by presenting and tracking performance against relevant standards
• To implement quality system in line with ISO/relevant standards by reviewing and understanding divisional SOP, analyse their impact in the local environment and effecting relevant aspects as required
• To identify discrepancies and investigate them via the available quality systems in a timely manner
• To identify and manage changes to processes, persons or systems, evaluate its impact and affected parties, implement planned actions and communicate as required
• To implement local CAPA management by identifying the probable root cause, proposing relevant corrective and/or preventative actions, executing the identified action and evaluating the effectiveness as required
• To conduct quality risk assessments using the quality risk assessment tools , identify risk areas, implementing risk mitigation/elimination measures,and monitor changes as required
• To ensure data integrity by creating, maintaining or implementing relevant SOPs
• To initiate or support quality audits by performing self-inspections, external audits. Identify audit queries, draft audit reports, engage with the relevant parties to implement corrective action and follow up on agreed actions
• To initiate annual mock recall and support actual recall process by informing the Health authority, liaising with the distributor(s) to facilitate product recall, contacting customers and reconciling the returned goods as required
• To maintain up to date knowledge of PQS by participating in physical trainings or provided in virtual learning platforms as required
• To perform training of personnel involved in GxP activities
• To maintain systems for reporting product complaints, including monitoring of the generic product complaints mailbox on business days
• To manage all complaints received based on the the applicable SOP
• Release commercial batches to the local market, and where applicable, Investigation Medicinal Products to the local clinical trial sites, according to the local regulations, Marketing Authorizations and Clinical Trial Authorizations
• To ensure all required KPI’s in the product release process are met and feedback is provided as required
• To support the returns process by implementing the relevant SOP,
• Ensure compliance with GDP guidelines and local regulations for the products distributed to the market
• Support batch traceability for all batches received and distributed by the local warehouse
• Coordinate with the supply chain responsible to manage additional controls for cold chain management
• To support the identification and selection process for GxP suppliers
• To create and maintain quality agreement with the GxP supplier
• To assist with oversight of warehouse and distribution business partners by monitoring compliance with the required standards stipulated in the quality agreement
• To ensure implementation of the SOPs, identify areas of concern and address these with the service providers until resolved
• Perform audits and assessment of contracted third parties
• To liaise with internal and external stakeholders by providing input on quality standards and procedures, liaising with them on procedures and building skills in the quality standards and procedure requirements as required

Qualifications

• University degree in one of the following or related science disciplines: pharmacy, medicine, pharmaceutical chemistry and technology, or biology
• 3 – 5 years’ experience in pharmaceutical or medical device environment, Regulatory and Quality Assurance Management
• Demonstrate evidence of maintaining and upholding rules and SOP’s

Must have knowledge of:

• Current regulatory framework and regulations
• Quality assurance and Quality Management within pharmaceutical environment
• ISO Standards

• Conduct regular management review of the QMS by presenting and tracking performance against relevant standards
• Implement quality system in line with ISO/relevant standards by reviewing and understanding divisional SOP, analyse their impact in the local environment and effecting relevant aspects as required
• Identify discrepancies and investigate them via the available quality systems in a timely manner
• Identify and manage changes to processes, persons or systems, evaluate its impact and affected parties, implement planned actions and communicate as required
• Implement local CAPA management by identifying the probable root cause, proposing relevant corrective and/or preventative actions, executing the identied action and evaluating the effectiveness as required
• Conduct quality risk assessments using the quality risk assessment tools , identify risk areas, implementing risk mitigation/elimination measures,and monitor changes as required
• Ensure data integrity by creating, maintaining or implementing relevant SOPs
• Initiate or support quality audits by performing self-inspections, external audits. Identify audit queries, draft audit reports, engage with the relevant parties to implement corrective action and follow up on agreed actions
• Initiate annual mock recall and support actual recall process by informing the Health authority, liaising with the distributor(s) to facilitate product recall, contacting customers and reconciling the returned goods as required
• Maintain up to date knowledge of PQS by participating in physical trainings or provided in virtual learning platforms as required
• Perform training of personnel involved in GxP activities
• Maintain systems for reporting product complaints, including monitoring of the generic product complaints mailbox on business days
• Manage all complaints received based on the the applicable SOP
• Release commercial batches to the local market, and where applicable, Investigation Medicinal Products to the local clinical trial sites, according to the local regulations, Marketing Authorizations and Clinical Trial Authorizations
• Ensure all required KPI’s in the product release process are met and feedback is provided as required
• Support the returns process by implementing the relevant SOP,
• Ensure compliance with GDP guidelines and local regulations for the products distributed to the market
• Support batch traceability for all batches received and distributed by the local warehouse
• Coordinate with the supply chain responsible to manage additional controls for cold chain management
• Support the identication and selection process for GxP suppliers
• Create and maintain quality agreement with the GxP supplier
• Assist with oversight of warehouse and distribution business partners by monitoring compliance with the required standards stipulated in the quality agreement
• Ensure implementation of the SOPs, identify areas of concern and address these with the service providers until resolved
• Perform audits and assessment of contracted third parties
• Liaise with internal and external stakeholders by providing input on quality standards and procedures, liaising with them on procedures and building skills in the quality standards and procedure requirements as required

• QMS maintenance
• CAPA implementation
• GxP regulatory compliance
• ISO Standards
• Quality assurance
• Quality Management
• Data integrity
• Auditing
• Risk assessment
• Change management
• Product complaint management
• Batch release
• GDP guidelines compliance
• Cold chain management
• Supplier quality agreements
• Stakeholder liaison

• University degree in pharmacy, medicine, pharmaceutical chemistry and technology, or biology
• 3 – 5 years’ experience in pharmaceutical or medical device environment, Regulatory and Quality Assurance Management
• Demonstrate evidence of maintaining and upholding rules and SOP’s
• Knowledge of current regulatory framework and regulations
• Knowledge of quality assurance and Quality Management within pharmaceutical environment
• Knowledge of ISO Standards