CMO Handling Sr. Specialist at Acino

New Cairo City, Cairo, Egypt -

Full Time

Start Date

Immediate

Expiry Date

12 Sep, 26

Salary

0.0

Posted On

14 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, GMP Compliance, CMO Management, Risk Assessment, Quality Assurance, GXP Auditing, Product Life-cycle Management, CAPA, Pharmacovigilance, Cross-functional Collaboration, External Supply Management, Technical Communication

Industry

Pharmaceutical Manufacturing

Description

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide. Job Responsibilities: Acts as Single Point of Contact / SPOC for all quality related activities at assigned external CMO. Provides quality presence, risk assessment and input to technical meetings with the external CMO and establishes good working relationships. Co-design and execute QMS for CMOs mgmt. and implement in the related site. Responsible for oversight the quality performance of the CMOs with corresponding KPIs set. Provide front-line support to manage all quality related issues. Responsible for coordination of all GMP related topics with the CMOs, related to operations and/or compliance. Provide communication with CMOs and customers. Having updated frequent TQA with each CMO. Oversight, coordinate and manage product life-cycle changes, product line extensions, or new product launches to ensure orderly and timely transitions of production flow. Adhere to internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training. Forward all of received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs with investigation owning heading to needed conclusions & CAPA. Auditing the CMO for all needed GXP related activities. Qualifications & Experience Bachelor’s degree in Pharmacy or Chemistry Extensive experience in GMP and the pharmaceutical industry Minimum of 5 years of professional experience in GMP-regulated environments, with a strong background in Quality and external supply Excellent communication skills, with the ability to build strong relationships quickly with external suppliers Objective-driven, team-oriented, and adept at cross-functional collaboration This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!

Responsibilities

Acts as the single point of contact for quality activities at external CMOs, overseeing quality performance and GMP compliance. Manages product life-cycle changes, audits GXP activities, and coordinates quality-related issues and CAPAs.