Founded in 1946, Fidia is an Italian multinational pharmaceutical company, with R&D, manufacturing, marketing and sales capabilities, and an extensive product portfolio, mainly based on Hyaluronic Acid, in strategic therapeutic areas such as Joint care, Eye care, Skin care, Specialty care, Health&Wellness care. Headquartered in Abano Terme (PD), Fidia extends its global reach through local partners and distributors in 120+ countries worldwide, as well as with wholly owned subsidiaries.
To strengthen our team in Egypt, we are looking for a Scientific Service Specialist to be based in Cairo. The position reports directly to the Country Manager.
The selected candidate will play a key role in ensuring the quality and compliance of company processes, acting as a point of reference both for local authorities and for the corporate group.
We are recruiting
Scientific Service Specialist
Responsibilities:
- Implement the Quality Management System to control the distribution of medicinal products, medical devices and any other Fidia’s products within the Territory according to the applicable standards, regulations and procedures.
- Manage and control the quality and correct documentation of all actions under its responsibility.
- Design, maintain local set of quality SOPs (related to good distribution practices), ensure local documentation management.
- Organize and manage continuous training activities for the personnel.
- Responsible for managing deviations, change control, CAPAs, complaints, recalls and all other topics related to the QMS.
- Organize self-audit related to GDP requirements and manage corrective action plan.
- Managing the external warehouse company and controlling of good distribution practices implementation in the site. Approving all service activities related to GDP.
- Managing that all necessary additional requirements regarding the products listed in the legislation are implemented and followed.
- Managing returned, rejected and recalled or counterfeit products, and give the final decision for the product, in conjunction with the MAH or Legal Manufacturer.
- Managing product complaints from receipt to answer to the customer in collaboration with the Headquarter and manufacturer if different form HQ.
- Be the Main Contact of local health authorities in coordination with corporate group for validation of communications.
- Supporting for regulatory inquiries from authorities related to recalls and to adverse events.
- Implement an approval process for suppliers and be in contact with distributor and suppliers
- Representing the company in interactions with regulatory authorities, maintaining compliance with local legislation.
Requirements:
- BSc. Of Pharmacy
- Registered pharmacist in Egypt with an active practice license.
- Minimum of 3 years experience in quality assurance
- Knowledge of quality assurance activities such as issuing procedure, complaint managements.
- Preferable knowledge of ISO 13485 standard and GDP
- Excellent command of Arabic and English.
- Strong leadership, organization, and compliance management skills.
- The selected candidate must not be registered as a pharmacist-in-charge, technical manager, or scientific office manager for any other company or pharmacy.
Our Offer:
Open ended contract as per the Egyptian Law
Compensation Annual Base Salary: from 358,000 to 447,000 EGP based on the experience.
Fidia benefits:
In Fidia you will have unlimited access to training and coaching programs aligned with market best practices and opportunities for professional development through participation in internal job posting processes, pension fund with company integration and healthfund, merit review and referral programs, company canteen, staff discounts and access to the flu vaccination campaign.
Fidia Farmaceutici promotes parity and inclusion in all its actions. All people from the status of candidate to that of employee and throughout the duration of their employment relationship are entitled to the same opportunities and protections regardless of gender identity, sexual orientation, ethnicity, migration background, religion, nationality, age. All company procedures are therefore drafted in compliance with the principles expressed in the previous point; any divergences should be promptly brought to the attention of the People & Culture Department.