QA Documentation Officer

About the company:

• Multicare is a well-established Pharmaceutical Company with diversified scope in both manufacturing and marketing of pharmaceutical products, supplements, cosmetics and medical devices.
• Multicare has 15 years of prominent existence in the local market and has almost 35 products marketed and more to come through the pipelines.
• Multicare Egypt for Pharmaceutical Industries is the manufacturing facility of Pharamcare for Trading Agency, which located at the Industrial Zone – New Cairo and its HQ at Maadi.
• We are one of the fast growing Pharmaceutical Companies in the market which has strong ambition and aspiration to be one of the key players not only in Egypt but also within the region.
• Our international alliances are effective in different countries, including Saudi Arabia, United Arab of Emirates, India and New Zealand with future aspiration to extend more business associations and affiliations in near future to further markets.

Job Purpose:

• Quality Assurance Documentation Officer will be responsible for assisting in the implementation and maintenance of the Quality Management System (QMS) by coordinating the revision, review, and approval of SOPs and other GMP documents ensuring compliance with applicable domestic standards and regulations.
• The scope of activities includes, but is not limited to, document control function, including document login, tracking, processing, distributing, and archiving; management of CAPA, change management, and non-conformance records; maintaining and facilitating the training program, stability studies and QS metrics; and participating in internal audits and supporting external audits

Designation: QA Documentation Officer

Location : Industrial Area, 3rd Settlement, New Cairo (Katamia)

Job Grade: QA01/QA03

Reporting to: Quality Assurance Head

Duties and Responsibilities:

• Performs QA document control function, including document login, tracking, processing, approval, distributing, and archiving in compliance to internal and external requirements
• Coordinates the revision, review, and approval of SOPs and other GMP documents
• Organizes and ensures accurate and reliable filing systems for the paper-based GMP documents
• Maintains and facilitates training programs including training matrix, training files, and annual audit of training files
• Processes and provides timely and accurate update of stability studies
• Reviews quality outputs, change control, validation and qualification documents
• Maintains change control and deviation processes for SOPs, master batch records, specifications, test methods, validation protocols/reports, technical protocols/reports, and other GMP documents
• Assists in Quality Investigations
• Generates Incident Reports, Change Controls and CAPA reports, including reviewing adequacy of root cause, corrections, corrective actions, preventative actions and effectiveness
• Updates and maintains Quality Assurance Operations logs and databases and generating metrics as needed
• Participates in internal audits and supporting external audits
• Responsible for developing and keeping copies of the required Batch Manufacturing Record (BMR) and Batch Packaging Report (BPR) for production.

Benefits:

• For the selected candidates, we offer a superb working environment and a challenging atmosphere.
• You can also look forward to a competitive salary and benefits package with room for talents and potential candidates to sharpen and advance their career forward supported by exposure, learning and development opportunities.