Responsibility and Accountabilities:

Be accountable for an effective Quality Management System established / implemented, maintained and operated in line with current GxP (e.g. GDP, GMP) requirements of PIC/S, local regulatory standards, and Mundipharma standards for all product classes. Awareness of trends in industry and implementing necessary changes.

Delegation of responsibility may be given to competent personnel; however, the accountability remains with the responsible person. Any delegated activities should be documented (keeping appropriate records) and approved - preferably in a RACI Matrix.

Including but not limited to as listed in below sections. And other tasks as assigned by supervisor in line with business and regulatory requirements.

1. Licensing

• Ensuring appropriate certification (e.g. GMP, GDP, GDPMDS, GDPMD, GQP, ISO, HACCP) is attained and sustained as required.
• Provide expert advice on licensing requirements for IAC.
• Ensure that correct licenses are held at all times, if necessary.
• Maintain and control the master list of products for IAC.
• Liaise with regulatory to ensure that the information in the product list is kept current and that all product information and labelling are in compliance with local and where applicable international regulations, codes and standards.
• Identify problems and implement effective solutions.
• Liaise with regulatory authorities in collaboration with the regulatory department for quality related matters.

2. Quality Managment

• Information to senior management if any aspect of the business or plant’s operations is not in accordance with GxP guidelines.
• Ensuring all aspects of product handling and distribution are performed in accordance with regulatory requirements, local quality standards and Mundipharma regulations.
• Implementation of quality and GxP regulations as well as any other relevant standards, maintaining awareness of trends in industry and implementing necessary changes.
• Ensuring external inspections, complaints, recall, deviations, CAPA, incidents of counterfeiting and tampering, supplier performance and other relevant quality performance measures are raised, investigated, reported, trended and communicated to those required and management.
• Ensuring suitability, approval and auditing of suppliers and customers etc. where applicable.
• Approving any subcontracted activities which may impact on GxP (e.g. GDP) or on corresponding equivalent (e.g. ISO etc.).
• Ensuring quality risk management principles. (E.g. Establishing emergency and safety plans, if applicable)

3. Personnel

• Ensures the initial and continuous training programme is implemented and maintained. Plans and records should reflect training activities.

4. Documentation

• Ensuring the management of authorized activities and the accuracy and quality of records. Records should be available as evidence and traceability of activities performed with respect to the quality, strength, purity, safety, identity and traceability of the product and integrity of the pack.
• Ensures that documentation and records are managed throughout their life cycle.
• Ensures an effective CAPA system for recording of all actions for correction, prevention and improvement, with monitoring for closure in a timely manner.

5. Operations

• Ensure the compliance of repacking, relabeling, storage, distribution and transport are in accordance with GDP or applicable regulations, licensing and Mundipharma standards and responsibilities defined by technical agreement and approved prior to use.
• Ensures changes related to product, third parties, key business activities, artwork, etc are raised, evaluated and implemented via a change control system. o Assisting in audit, approval, supervision and co-ordination of third party activities.
• In cases where a distribution IAC is also a Marketing Authorisation holder for a product, to ensure the performance of Annual Review or Trend analysis of products; evaluating the results and taking appropriate action and in a timely manner to facilitate reporting of the restriction in supply (for example due to manufacturing constraints) to the relevant competent authorities, in accordance with its legal obligations.
• Ensuring that batches of products should not be transferred to salable stock before assurance has been obtained in accordance with written procedures, that they are compliant and authorized for sales. (i.e. decision for market release of product).
• Ensuring that any additional requirements imposed on certain products by national legislation are adhered to. (E.g. Surveillance of the quality of Mundipharma products and the compliance with legal requirements).
• Ensure that Mundipharma security procedures are implemented for controlled drugs.
• Ensure that due diligence and quality evaluation is performed as per Mundipharma procedures and policies.
• Ensures that controlled drugs are managed as per authority requirements, including reconciliation and witness of destruction.

6. Complaints, Returns, Suspected Falsified Products and Product Recalls

• Establish and maintain receipt, investigation, tracking, trending and communication of complaints. This includes notification to authority as per the current regulatory requirements. Ensure escalation and notification in line with regulatory and Mundipharma standards and timelines.
• Deciding on the final disposition of returned, rejected, recalled or falsified/counterfeit products.
• Approving of any returns to saleable stock.
• Ensure an effective process for the management of Rapid Alerts (e.g. Field Alerts, Field Safety Notice Field Safety Corrective actions, etc.).

7 Self-inspections

• Ensuring that internal audit programme is established, maintained and communicated. Actions identified should be tracked as CAPA. Schedule should reflect requirement for audit on at least an annual basis.

Qualifications and Experience:

• Degree in Pharmacy, Chemistry or related disciplines/ Registered Pharmacist.
• A minimum of 5 years' experience in GxP (e.g. Good Distribution Practice) for at least one of the preferred categories or equivalent.
• A minimum 3 years being responsible for the operational management of a GDP/ GMP Quality Management System including decision making for product release or equivalent.
• Trained internal auditor for GMP/GDP
• Proficient in the use of Microsoft Office Applications
• Fluent in Spoken and Written English

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