Job Description

Roles & Responsibilities

Description:

We are looking for a talented Associate Manager, Quality Compliance to join us. At Hikma you ll be supported by a culture of progress and belonging where people are encouraged to develop, wellbeing is prioritised and our inclusive approach values contributions from all. We re seeking candidates who embody our values: Innovative, driven to keep learning; Caring, genuinely compassionate in their work; and Collaborative, eager to solve problems together.

If you want to be part of a team that cares about impact, this is the place for you.

Key Responsibilities:

Strategic

• Providing support and guidance to the Hikma injectable sites including compounding by:
• Lead auditing coordination, approach, and execution for injectables/Oral/ laboratory/Data Integrity manufacturing/contract manufacturing CMOs
• Ensuring internal injectable/Oral Hikma site compliance with Hikma s rules and policies through internal audits
• Following up on all observations by Hikma and third parties which includes CAPA plan implementation and ensuring timely completion.

Technical capabilities

• Providing concerned Hikma employees with the required guidance related to the injectables/Oral/laboratory/Data Integrity manufacturing/contract manufacturing CMOs manufacturing processes to ensure that the related international standards and specifications are applied on all Hikma concerned processes
• Investigating and studying different problems related to injectables/Oral/ laboratory/Data Integrity manufacturing/contract manufacturing CMOs manufacturing processes that might occur in all Hikma concerned functions and recommending the corrective actions accordingly
• Ensuring that health and safety regulations are followed in the concerned processes to avoid accidents in the workplace during executed audits protecting the auditors
• Ensuring that the entire injectables/Oral/laboratory/Data Integrity manufacturing/contract manufacturing CMOs manufacturing processes are in compliance with the set standard operating procedures (SOPs
• Ensuring that all injectables/Oral/laboratory/Data Integrity manufacturing/contract manufacturing CMOs manufacturing processes, activities, procedures comply with related internal/external regulations
• Conducting periodic checks to ensure that all injectables/Oral/laboratory/Data Integrity manufacturing/contract manufacturing CMOs manufacturing processes are performed correctly and conforming the international standards and specifications
• Assessing different Hikma functions compliance with the set standards and specifications in order to detect the deviations and recommending the necessary corrective actions accordingly
• Providing the Corporate Compliance Director with periodic reports illustrating the work flow of the injectables/Oral/microbiology, laboratory/Data Integrity manufacturing/contract manufacturing CMOs manufacturing processes through Hikma corporate functions
• Documenting different related transactions in all Hikma corporate functions to be used as a reference in the future when needed
• Performing other duties related to the job as assigned by the direct supervisor

Administrative

• Preparing periodic reports with respect to the Compliance (Injectables/Orals) function's activities and achievements to be submitted to the direct supervisor
• Ensuring that instructions, circulars and organizational and technical decisions are followed and applied
• Implementing Internal quality auditing and Hikma subsidiaries audit program, ensuring that Hikma Internal sites maintain a state of cGMP compliance where all activities within the Hikma Pharmaceutical function comply with the adopted standards, policies, and procedures.
• implementing follow up auditing program for Hikma internal sites, ensuring that response is covered and communicated properly with Hikma quality management.
• Providing Technical Support to Injectable/Oral strategic Under license projects, by qualifying suppliers, upgrading systems of our partners, conducting gap analysis and providing the needed support before/ during and after authorities audits to sites, up to end of registration of the product.
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Qualifications:

We are looking for candidates whose experience and skills align closely with the qualifications outlined below:

• B.Sc. degree in Chemistry, Biological, Microbiology, Chemical Engineering or equivalent
• M.Sc. degree in TQM or equivalent
• (10) years of experience in a related position, of which at least (5) in a supervisory position
• Experience in a pharmaceutical industry, Oral and Injectables manufacturing.
• Quality certification on auditing e.g. ASQ/ISO9001 . etc

Skills:

• Computer Skills

Performs moderately difficult tasks using job related applications, Office applications, and other relevant programs, as well as uses the functions of the internet effectively

• Data Analysis

Performs complex data analysis utilizing multi-sourced set of data, prepares reports illustrating the results through professional graphs, charts, and other visual aids

• Documentation / Recording Information

Applying and using various techniques in documenting and recording information in written or electronic/magnetic formats

• English Language

Demonstrates mastery of the language; near native; ability to read, understand and write extremely difficult or abstract prose, a wide variety 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 & Legislations

Possesses knowledge in laws and legislations of several countries that Hikma operates in, including MENA region, USA and Europe

• Project Management