QA Manager and Responsible Person - Romania Affiliate

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1. Role of the Position

Fulfils all duties of the Responsible Person as defined in the Good Distribution Practice (GDP) Guidelines:

Coordinates all wholesale distribution activities of finished pharmaceutical products and medical devices within the company in accordance with MOH Order 131/04.02.2016 (Rules regarding the establishment, organization, and operation of wholesale distributors of medicinal products for human use) and MOH Order 761/17.06.2015 (Good Distribution Practice Guidelines).

Has relevant knowledge of Law 95/2006, republished, with subsequent amendments and additions.

Ensures the implementation and maintenance of the Quality Management System as defined in the GDP guidelines and internal Lilly global standards.

2. Responsibilities

Ensures that a Quality Management System is implemented and maintained

Verifies, from a GDP/ GMP perspective, procedures developed together with Quality Assurance

Manages authorized activities

Ensures implementation and maintenance of initial and ongoing training programs

Coordinates and promptly performs medicinal product recall operations

Ensures effective handling of quality complaints

Ensures that suppliers and customers are approved

Approves subcontracted activities that may impact GDP

Ensures that self-inspections are conducted regularly according to a predefined schedule

Ensures that corrective and preventive actions are implemented

Maintains records of delegated tasks

May delegate tasks but not responsibilities

Makes decisions regarding the final disposition of returned, rejected, recalled, or falsified products

Approves reintroduction into saleable stock of returned products

Ensures compliance with all additional requirements under Art. 790 letter b) of Law 95/2006, as amended

Ensures compliance with public service obligation

Requests marketing authorizations (MA) for all distributed products

Verifies certificates of analysis, quality certificates, and their records

Is responsible for implementing the emergency plan as specified in the product recall procedure when required by competent authorities and prepares the related documentation

Verifies recorded temperature values in storage areas and transport means of suppliers, ensuring compliance with manufacturer specifications and applicable legislation

Periodically archives storage and transport condition records according to procedures

Records deviations identified during the distribution process and participates in their investigation and resolution according to the SOP for deviation management

Participates in the preparation of the risk register by identifying GDP-related risks

Ensures that all risks related to GDP/ GMP processes are identified, recorded, evaluated, and managed according to the quality risk management procedure

Ensures that change control related to GDP/ GMP activities is performed according to procedure and approves implementation of action plans

Ensures that responsibilities related to the management of serialized medicines are implemented

Ensures monthly reporting to ANMDMR of distributed medicines (electronic and/or paper format)

Submits daily SER reporting to the Ministry of Health

Periodically participates in training and professional development courses relevant to the activity

Ensures that outsourced distribution activities to the Logistics Service Provider are performed in compliance with GDP, legislation, and contractual provisions

Periodically audits outsourced activities to verify compliance with GDP guidelines

Performs periodic stock reconciliation

Records goods receipt and processes customer orders

Verifies compliance with contractual terms and conditions with customers from a GDP perspective

In case of a quality complaint, promptly notifies the supplier/manufacturer or Marketing Authorization Holder (MAH)

In case of identification of falsified or suspected falsified medicines, notifies the manufacturer/MAH and ANMDMR

Maintains records for all returned, rejected, recalled, or destroyed medicinal products

Collaborates directly with the Responsible Person of the Logistics Service Provider for the supervision and execution of subcontracted activities

3. Education: University Degree – Faculty of Pharmacy

4. Specific job requirements:

Membership certificate issued by the Romanian College of Pharmacists.

At least 5 years’ experience in Quality Assurance and as Responsible Person role (covering the handling, storage and distribution of finished pharmaceutical products and medical devices).

Hold knowledge of Law No. 95/2006, MOH Order 131/04.02.2016, GDP Guideline (Order 761/2015) and any other European and local regulation related to the distribution of finished pharmaceutical products and medical devices.

Knowledge in Quality Management Systems (policies, procedures, computerized systems, GMP/ GDP records, third-party management, regulatory inspections).

5. Additional Skills/Preferences:

Proficient in using Quality Management software and tools (e.g SAP, Veeva Vault, Success Factor, etc).

Excellent communication skills.

Capability to carry responsibility, work under pressure, strategic thinking, analytical skills and flexibility.

Proven leadership skills.

Problem solving attitude.

Strong conduct of integrity.

6.  Languages: Romanian (native); f luent in written and spoken English.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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