Quality assurance Specialist:

The Quality Assurance Specialist is responsible for providing comprehensive technical support and quality assurance oversight to meet good distribution practices and the requirements of applicable Health Authorities and suppliers’ standards. He supports the goods reception, storage, and distribution. He ensures that ALFA product(s) consistently meets our customer and regulatory requirements and the suppliers’
standards. This position will work closely with Logistics, Clearance, Warehouses, and Distribution in addition to contract manufacturers to ensure compliance with applicable regulations, quality agreements and SOPs of both internal and external operations.

Pharmacovigilance specialist:
Pharmacovigilance specialist makes sure that the suppliers are informed in a timely and accurate fashion of safety issues concerning their products and can thereby act appropriately to safeguard the interests of patients and health-care professionals while complying with legal/regulatory requirements concerning adverse event monitoring and reporting. He/she makes sure that adverse Event reports are processed in an accurate and timely fashion in accordance with regulatory requirements.
The Specialist provides prompt and accurate responses to Medical Information requests from customers about all products imported by Alfa
healthcare

• Duties and Responsibilities:
  Quality assurance Specialist:
•  Liaison with suppliers to facilitate the completion of product complaint investigations and ensure that investigation reports are completed in a timely manner.
•  Gather additional information regarding a reported complaint
•  Assess incoming complaints and escalate issues that require management’s immediate attention.
•  Identify complaint samples requiring additional analysis and initiate and track sample shipment.
•  Write product complaint summary reports and response letters to ALFA customers and route for cross functional approval.
•  Analyze final evaluations and written summaries to assess technical and regulatory compliance and resolve issues with suppliers.
•  Lead and participate in meetings and projects to communicate and resolve system and quality issues tied to product complaints.
•  Create, assemble and maintain final product complaint report packages in QA for reference and presentation during regulatory agency inspections.
•  Report metrics and trends of product complaint program and other quality systems as assigned.
•  Execute and participate in internal and external audits.
•  Participate as inspection support team member during regulatory compliance audits and inspections.
•  Develop SOP and improvement initiatives of quality systems. Assist in other areas of QA. Follow up closure of CAPA. Investigate any deviation in implementing the SOP.
•  In care of a recall, oversight the recall process and ensure that the recall SOP is followed.
•  Review the warehousing standards, and ensure that standards are met and SOPs are followed.
•  Review the policies and procedures in place to ensure the appropriate storage, dispensing, and use of all medicines. These procedures should include at a minimum an explanation of the following;
•  Pharmaceutical distribution and control procedures (inventory control and management system).
•  Provision for appropriate storage and transport and proper management of the deviation following up on CAPA.
•  Cold chain procedures that are enforced explicitly
•  Appropriate dispensing and use procedures; Containers, Labeling, Counseling the patient  Avoidance of repackaging unless appropriate quality control is in place
• Pharmacovigilance specialist:
•  Provide high quality, balanced and timely information to requests for medical information from both internal and external customers.
•  Maintain a database of the Medical Information requests and responses.
•  Maintain references and other Medical Information resources.
•  Receie and initially process product complaints; forward information to the supplier.
•  Report adverse events to the supplier of the product according to
  regulations and standard operating procedures.
•  Maintain a log, compliance information and filing system for all pharmacovigilance cases.
•  Provide pharmacovigilance training to internal staff.
•  Actively participate in departmental and various cross-functional
  project teams that may include Regulatory, Sales and Marketing, and Medical Affairs.
•  Participate in personal development and training sessions.
•  Work in a safe manner that does not endanger yourself or co-workers.
•  Execute other duties as may be required by the direct manager and
  other members of Alfa Leadership Team as training and experience allow.
•  Providing safety log to the suppliers on a monthly basis or as required by the suppliers.
  

  hr@alfahealthcare.com