Job Description

Sudair Pharmaceutical company is looking for a Quality Assurance Officer in Sudair Industrial city.

Job summary:

The Quality Assurance Officer is responsible for supporting the quality system processes and for maintaining and controlling quality assurance standards and documents.

The Quality Assurance Officer collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, Regulatory Affairs, and Research and Development. The individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position reports directly to the Quality Assurance Manager.

Responsibilities:

• Oversee the generation, review, and archival of documents used to support Good Manufacturing Practice.
• Assist with writing, revising, and approving standard operating procedures.
• Providing support to the site, including review of master, and executed operational GMP documentation; this being the primary focus of the role.
• Ensure that all work carried out onsite follows the required standards.
• Providing Quality support for validation & qualification activities.
• Coordinating and performing (under supervision) internal and external audits.
• Facilitating timely follow-up and closure of Deviations, Change Controls and CAPA.
• Responsible for document management systems.
• interpret and implement quality assurance standards and procedures.
• Assist in investigations and resolve potential product quality issues to improve efficiency.
• May perform additional duties as required.

Qualifications:

• Bachelors’ degree in a scientific discipline.
• 2–3-year experience in cGMP environment within relevant Quality Assurance/Compliance functions.
• Understanding and hands-on working knowledge Good Laboratory Practice (GLP) and Good Manufacture Practice (GMP).
• Reliable, flexible, stress resistant, ability to work with minimal supervision and good interpersonal ship.
• Excellent writing/communication skills.