QC Documentation Officer

 Medichem Manufacturing (Malta) Ltd and Combino Pharm (Malta) Ltd form part of the Medichem group, a Spanish pharmaceutical organization which develops and manufactures both active pharmaceutical ingredients and finished dosage forms. 

Medichem specialises in active pharmaceutical ingredients, while Combino Pharm is focused on solid oral generic pharmaceutical products. The organization provides high quality medicinal substances and products for the worldwide market, with special emphasis on Europe and the US. 

The two factories are located side-by-side in the Hal Far Industrial Estate, hold EU GMP certification and US FDA approval, and have been operating here in Malta for 20 years. We are currently looking for a new team member for the following role: 

QUALITY CONTROL DOCUMENTATION OFFICER 

We are looking for a QC Documentation Officer within Combino Pharm (Malta) Ltd. who will be responsible for preparation, review, and issue of QC documentation, in full compliance with cGMPs and company procedures. Moreover, the selected candidate will be required to perform QC related functions according to the exigencies of the Company. 

The Position Requires: 

• Writing/preparing analytical methods and specifications, including but not limited to status of analysis documents, chromatographic proformas and analytical records. 
• Support in documentation related to method validation, process validation, cleaning validation, and stability studies. 
• Issuing of COAs for QC Management approval. 
• Assisting the QC Manager in drafting/revising SOPs relevant to QC operations. 
• Ensuring that all pharmacopeial standards are in compliance with current pharmacopeias and are reflected in internal documents. 
• Participate in the management, co-ordination and timely execution/closure of change controls, deviations and CAPAs. 
• Creation of specifications and master of tests in the MRP system. 
• Co-ordination and management of client sample requests 

Selected Person Will Be: 

• In possession of a higher qualification in Chemistry or Pharmaceutical science. 
• A minimum of two years experience in a pharmaceutical QC environment. 
• Extremely organised and possess excellent communications skills. 
• Able to work independently as well as in a team environment. 
• Self-motivated and have excellent attention to detail.
• Results oriented and will display an attitude that reflects our Company values.

What Does Medichem Offer You: 

• Continuous opportunity for professional growth and training. 
• A competitive salary. 
• Health insurance. 
• Medical check-ups. 
• A culture where teamwork is priority. 
• A positive working environment with an employee focused approach. 
• Job security.