Quality Assurance Manager

Job Purpose:

Provides general Quality Assurance (QA) activities, including but not limited to SOP and policy development and oversight, training compliance, audit activities, and oversight of CAPA investigations and root cause analysis. The QA Manager collaborates closely with operational teams and functional areas and reports directly to the Head of QA.

Duties and Responsibilities:

• Responsible and Accountable for all Quality Management Systems at the Plant
• SOP management and implementation of the Corporate quality guidelines
• Ensure that all documentation is updated daily, and all regulatory and statutory requirements are complied with.
• Ensure optimum usage of all manpower resources and train and develop them to achieve their deliverables.
• Ensure that the products manufactured are to the exacting standards of Pharmacopeia with zero defects and zero product recalls.
• Periodic Audits and self-inspection to ensure that all the requirements of cGMP are maintained and that the plant is always 100% audit ready.
• Attend operational matters such as BMR and Batch release, OOS, and product complaints/Recalls
• Generate relevant and accurate MIS

Designation: Quality Assurance Manager

Location: Africure Pharmaceuticals Manufacturing Ethiopia PLC Manufacturing Site - Kilinto Industrial Park, Addis Ababa

Reporting: Plant Head

Job Requirements

Qualification, Knowledge, Experience

• A Bachelor’s degree in a related field from an accredited college or university, or equivalent experience.
• A minimum of five years of experience in the pharmaceutical industry with at least three years in quality assurance, or an equivalent combination of education and experience.
• Thorough knowledge of GxP, ICH GCP, and 21 CFR.
• Audit experience (hosting and/or conducting).
• Thorough knowledge of CAPA and root cause analysis.

Language

• Excellent verbal, written, and interpersonal communication skills. Fluency in at least English and Amharic is essential

IT Literacy

• Professional computer and MS-Office skills

Competencies and Behaviors

• Strong organizational and multitasking skills
• Professional ability to troubleshoot and resolve manufacturing problems in a pharmaceutical manufacturing environment
• Superior skills with regard to data analysis and business process analysis and design
• Strong interpersonal and oral/written communication skills
• Proven leadership skills
• Attention to detail
• Fundamental understanding and application of project management principles and skills
• Strong aptitude towards usage of automated systems; technology-focused
• The drive for self-development, the ability to collaborate, and an action-oriented work ethic

How to Apply

Please send your applications by email with a cover letter, resume/CV, and copies of all qualifications and credentials.

The title of your email should state the specific position you're applying for. Address your application to [email protected] within the 3 weeks period this advert is on air