Embark on a rewarding role as a Senior QARA Specialist, playing a key role in ensuring quality and compliance in the pharmaceutical sector. . Effective communication, organizational prowess, and leadership acumen are imperative. Join the team in maintaining the highest standards in pharmaceutical quality and regulatory adherence.

Senior QARA Specialist & Responsible Pharmacist will be based in Algiers, Algieria.

At DNA Recruitment, we carefully review all applications and aim to contact every suitable candidate within max. 5 working days. If you don’t hear from us, please consider your application unsuccessful on this occasion.

Responsibilities

Senior QARA Specialist & Responsible Pharmacist will be responsible for ensuring that CQA processes are in place in the region:

• Local Complaint Coordinator activity
• Product Surveillance activity for Medicinal Products and Medical Devices
• Field Action execution

Supplier & Distributor Management:

• Senior QARA Specialist will implement the Quality System in the region and audit management.
•  NCR, CAPA, and Change Management.
• Selling Authorizations and release of products according to local requirements.
• Make sure that backup persons for critical processes in the region are appropriately trained and backups are always available.
• Ensure that processes and procedures related to the mentioned activities comply with local regulations, the Corporate Quality Manual, and ISO 9001 and 13485 requirements.
• Ensure that RA processes are in place in his / her region:
• Proactively monitor, review, interpret, and translate all national regulatory requirements of the Medicines Regulatory Authority
• Develop and implement strategies for the earliest possible regulatory approvals to support business plans
• Maintain good standing with the local regulators and effectively manage the regulatory activities per the company’s expectations.
• Ensure appropriate maintain of contacts with the country Supply Chain, Pharmacovigilance, TS, W&D, and Businesses.

As the Responsible Pharmacist:

• Senior QARA Specialist will ensure company compliance with applicable Acts and regulations and cGMP in controlling medicines and medical devices distributed and sold by the company.
• Assume the tasks of the Responsible Pharmacist of the company’s entity in Algeria as defined by the local regulations.

Local Complaint Coordinator:

• Senior QARA Specialist will ensure a process and procedures are in place for logging and investigating complaints.
• To notify the authorities of reportable Complaints.
• To train the customer-facing employees on the complaints Handling Processes.
• To close complaints with Customers and Authorities.
• To ensure backup, LCCs are appropriately trained, and backup is always available.

Country Product Surveillance activity for Medical Devices:

• Senior QARA Specialist will ensure effective gathering, recording, transmission to the ProductSurveillance team and reporting to the competent Authorities of medical deviceadverse events.
• Collect, follow-up, and transmit all local incidents and near incidents to CTPS(Central Team Product Surveillance) using the Global tracking system and archive relevant documents.
• Set up and maintain an efficient Product Surveillance system in compliance with the national medical devices regulations and with the company’s standards.
• To ensure appropriate contacts with other functions, such as Technical Services, Sales and Marketing, etc., that may be involved in this process.

Manage and execute Field Corrective Actions:

• Senior QARA Specialist will be the local FA Coordinator, ensuring execution of FAs according to the corporate, EMEA, and local Procedures.
• To communicate with MOH and customers.
• To ensure timeous execution, reconciliation, and closure of FAs.
• To ensure backup, local FA Coordinators are appropriately trained, and backup is always available.

Distributor Control:

• Senior QARA Specialist will manage the distributor/Third parties’ assessment program.
• To perform and document third-party audits and supervise the performance of corrective actions for deficiencies.
• To train distributors on the QMS requirements.
• To sign QA agreements defining the company’s and distributors’ QA responsibilities.

Supplier QA:

• Senior QARA Specialist will manage the supplier QA program of sponsoring Divisions for products and parts sourced in the region (in cooperation with Divisions).
• To maintain the approved supplier list.
• To sign QA agreements where applicable, defining company’s and supplier Responsibilities.

Audit:

• Senior QARA Specialist will prepare for internal and external assessments and ensure positive outcomes.

Training:

• Senior QARA Specialist will ensure that systems are in place and maintained to train employees on equality system compliance (including new SOPs).

• To ensure that training records are maintained.
• To ensure that Distributors and service providers are trained on GDP and the company’s requirements.

Compliance:

• Senior QARA Specialist will ensure that the company’s regional workshops comply with applicable national laws and SOPs requirements.
• To work with regulatory bodies on external audits & prepare responses
• To conduct Distributors GDP audits.
• To implement Good Distribution Practices within the region.
• To ensure the release of the company’s products to local requirements.

QMS & Documentation:

• Senior QARA Specialist will implement the applicable company’s SOPs in the region.
• To ensure all relevant SOPs are in place to meet Corporate Quality Manual requirements and ISO 9001 and 13485 standards.
• To manage the preparation of new SOPs for the region and the distribution, obsoleting & filing of quality documents.

NCR, CAPA, and Change Management:

• Senior QARA Specialist will initiate and investigate non-conformances (NCR) in the region and implement Corrective and Preventive Actions as identified.
• To manage the Change Control process in the region.

Selling Authorizations:

•  Senior QARA Specialist will ensure that products are sold only to authorized entities and fully comply with local regulations and requirements.

Become an ERP System SME in the region:

• Senior QARA Specialist should be an expert in distribution-related aspects of JDE and other ERPs.
• Ensure that backup for ERP expert user functions in his / her region are appropriately trained, and backup are always available.
• Ensure processes and procedures are in place for his / her region as applicable.

Other Quality aspects:

• Senior QARA Specialist will manage temperature-controlled shipments in the region.
•  To maintain and train backups of critical tasks (PQCs, MDRs, FAs, Releases).
•  To define and control the quality aspects of third-party warehouses.
•  To establish and maintain sample rooms (where required) within the theScientific Offices in the region.

Regulatory Affairs:

• Senior QARA Specialist will deliver the annual product submission plan.
• Compiling/overseeing the submission of dossiers according to the annual product submission plan to Regulatory Authorities within the region.
• Due diligence on prospective dossiers from the company as well as other 3rdparties.
• Delivery of Future Registrations.
• Continuous liaison with Regulatory Authorities to ensure new productregistrations are received on time to satisfy the requirements of the business.
• Compile/oversee that recommendations are responded to timeously.
• Product registration Life Cycle Management: ensuring that necessary updates are made to the Registration Dossier according to the latest requirements of the Regulatory Authorities.
• Ensuring timely approval of post-registration variations to avoid out-of-stock.
• Ensuring that the Regulatory Authority is informed of changes to the registration dossier.
• Printed Packaging Material Review: Review for compliance with the registered dossier and final approval before print.
• Liaising with the company head office on all regulatory activities.
• Coordinating GMP/GCP inspections of the parent company’s manufacturing facilities with inspectors from the various Regulatory Authorities.
• Controlling correspondence with other pharmaceutical companies and pharmaceutical consultants with regard to regulatory activities.

Responsible Pharmacist to maintain compliance with applicable Acts and regulations and cGMP:

• Senior QARA Specialist will be responsible for PV, QA, and RA communications with health authorities.
• Will be the nominated pharmacist in charge of the organization’s operating establishment and the official responsible pharmacist for all PVQARAcommunications.
• The organization’s point of contact will be nominated for all PV & QA activities before the MOH.
• Ensure company compliance with applicable Acts and regulations and cGMP in controlling medicines and medical devices distributed and sold.
• Prepare for MOH audits and ensure satisfactory outcomes.
• Act as Person Responsible for Pharmacovigilance (RPV) as required and contact point in Algeria on a 24-hour basis and also as a contact point for pharmacovigilance inspections.
• To fulfill the requirements of the local Algerian legislation for pharmacovigilance.

Qualifications

• At least 3 years of professional experience is required in the quality and regulatory fields.
• At least 2 to 4 years of experience is required as a Responsible Pharmacist.
• Pharmacy’s Degree.
• Ability to liaise with internal and external stakeholders: Pharmacovigilance, W&D, Supply Chain, Compliance, Technical Services, Business, RegulatoryAuthorities, Third Party partners.
• Good Knowledge of GMP, GDP, ISO 9001, ISO 13485, and local regulations.
• Fluent in English, French & Arabic.
• Stress resistance and ability to work in a rapid response environment.
• Excellent communication skills, both verbal and written.
• Good organizational skills and the ability to multitask.
• Strong listening skills.
• Strong team player with a flexible approach, yet able to work unsupervised and under pressure.
• Self-motivated with a high level of initiative.
• Good Scientific knowledge and project management skills.
• Ability to identify compliance risks and escalate when necessary.

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