Quality Compliance Lead – Pharma Audits & GMP

Hikma Pharmaceuticals; Sintra; Presencial; EUR 70 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Direct contract with Hikma

Competitive salary

Life insurance

Health Insurance extended to student</

Resumo da oferta

Hikma Pharmaceuticals in Portugal seeks an Associate Manager, Quality Compliance to join the Quality Compliance - Corporate department reporting to the Sr. Director.

The role focuses on audits across injectable, oral, laboratory, Data Integrity, and CMOs, ensuring site compliance with internal policies and international standards. The ideal candidate has a strong background in pharmaceutical quality systems, audits, and CAPA management, with extensive experience in multi-site quality control and

Qualificações

• B.Sc. degree in Chemistry, Biology, Microbiology, Chemical Engineering or equivalent.
• M.Sc. degree in Total Quality Management or equivalent.
• Quality auditing certification, such as ASQ, ISO 9001 or equivalent.
• 10 years of experience in a related position, including at least 5 years in a supervisory position.
• Experience in the pharmaceutical industry, including oral and injectable manufacturing.
• Data analysis and reporting using graphs, charts and related visual aids.
• English language mastery with high proficiency in reading/writing.

Responsabilidades

• Lead the coordination, approach and execution of audits for injectable, oral, laboratory, Data Integrity manufacturing processes and CMOs.
• Ensure compliance of Hikma sites with Hikma rules and policies through internal audits and periodic checks against standards and SOPs.
• Follow up observations, CAPA plan implementation and communication with Quality Management.
• Provide guidance on injectable, oral, laboratory, Data Integrity and CMO processes to ensure compliance with international standards.
• Investigate problems and assess deviations, recommending corrective actions.
• Implement internal quality auditing, subsidiary and follow-up audit programmes to maintain cGMP compliance and health & safety during audits.
• Support under-license and new partner projects, including supplier qualification and system upgrades.
• Prepare periodic reports, support process standardization and participate in third-party or authority audits.

Descrição da oferta de emprego

Hikma Pharmaceuticals in Portugal seeks an Associate Manager, Quality Compliance to join the Quality Compliance - Corporate department reporting to the Sr. Director.

The role focuses on audits across injectable, oral, laboratory, Data Integrity, and CMOs, ensuring site compliance with internal policies and international standards. The ideal candidate has a strong background in pharmaceutical quality systems, audits, and CAPA management, with extensive experience in multi-site quality control and