Associate Manager, Quality Compliance

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

Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people in need. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve.

At the end of the 1980s, we extended ours beyond the Middle East and acquired land in Portugal for the construction of a sterile factory for injectable pharmaceutical products. This was an important turning point for the company, and our first step into a new region. Today, in Portugal, we have more than 1000 employees and 3 factories for the production of injectable medicines.

Hikma intends to recruit an Associate Manager, Quality Compliance - (m/f) to integrate the Quality Compliance - Corporate department reporting directly to the Sr. Director, Quality Compliance

Main Responsibilities

• Lead the coordination, approach and execution of audits for injectable, oral, laboratory, Data Integrity manufacturing processes and contract manufacturing organizations (CMOs).
• Ensure compliance of Hikma injectable and oral sites with Hikma rules and policies through internal audits and periodic checks against applicable standards, specifications and SOPs.
• Follow up observations raised by Hikma and third parties, including CAPA plan implementation, timely completion and communication with Hikma Quality Management.
• Provide guidance to concerned Hikma employees on injectable, oral, laboratory, Data Integrity and CMO manufacturing processes to ensure that applicable international standards and specifications are followed.
• Investigate problems and assess deviations related to the concerned manufacturing processes, recommending the necessary corrective actions.
• Implement internal quality auditing, subsidiary audit and follow-up audit programmers, ensuring that Hikma sites maintain cGMP compliance and that health and safety regulations are followed during audits.
• Provide technical and administrative support to under-license and new partner projects, including supplier qualification, system upgrades, gap analysis and support before, during and after authority audits up to product registration.
• Prepare periodic reports and documentation, support process standardization, participate in third-party or authority audits and perform other duties assigned by the direct supervisor.

Profile

• 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.
• Computer skills: Performs moderately difficult tasks using job-related applications, Microsoft Office applications and other relevant programs, and uses internet functions effectively.
• Data analysis: Performs complex data analysis using multi-sourced data and prepares reports presenting the results through professional graphs, charts and other visual aids.
• Documentation and recording information: Applies and uses various techniques to document and record information in written or electronic formats.
• English language: Demonstrates mastery of the language, with near-native ability to read, understand and write extremely difficult or abstract prose and use a wide range of vocabulary, idioms, colloquialisms and slang.
• Government relations: Represents the company externally within the government sector and develops and maintains good rapport with its employees.
• Laws and legislations: Possesses knowledge of the laws and legislations of several countries where Hikma operates, including the MENA region, USA and Europe.
• Project management: Ability to manage projects through effective planning, implementation, monitoring and completion, while ensuring the best use of time, human resources and budget.

We Offer

• Direct contract with Hikma
• Competitive salary aligned with the role
• Life insurance
• Health Insurance extended to student children (up to age 24)
• Annual Performance Bonus
• Real Growth Opportunities