Production 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.

We are currently looking for a new team member to join Combino Pharm in Malta, for the following Production Officer role:

Responsibilities and Functions:

· Issue, review and update production documentation like Standard Operating Procedures, master Production Batch Records, proformas and logbooks.

· Assist in the review of executed batch records.

· Support in training to the production personnel related to quality aspects.

· Ensure that production activities are compliant with site quality systems and regulatory requirements.

· Support and implement GMP industry standards across the production department.

· Collaborate in internal and external functions to ensure appropriate management of the artwork changes and other relevant documentation.

· Collaborate with the Quality Management Department so as to maintain GMP in a sustainable compliance status and to address solutions to productivity and supply issues through the issuance and implementation of required documentation such as Change Controls, Deviation Reports, responses to Customer Complaints, PQRs and other investigation activities like root cause analysis and managing of Corrective And Preventive Actions.

· Collaborate and respond to internal and external audit observations on the production department.

· Responsible to issue cleaning validation documents/procedures/protocols in support to the manufacturing processes (e.g. equipment, facilities, cleaning and process validations)

· Evaluate and ensure that cleaning validations are consistent with current GMP and FDA standards, client policies and procedures, and with any other regulatory agency as applicable.

· Implement quality systems to monitor cleaning processes supporting risk assessment and control activities.

· Identify and coordinate activities and tasks required to complete qualification and validation activities including reviews with Quality, obtaining signature approvals, and executing cleaning qualification protocols or cleaning validation projects.

· Assist in resolving and documenting technical and project- issues providing technical assistance to the Quality and Production departments.

Requirements:

· Higher qualification in Pharmacy/Chemistry/STEM or equivalent.

· Ideally previous exposure to FDF environment.

· Excellent oral and written communication skills in English.

· Self-motivated and have excellent attention to detail.

· Results oriented and will display an attitude that reflects our Company values.

· Able to work independently and in a team environment.

· Extremely organised.

What Does Medichem Offer You

· Private Health insurance.

· Regular Medical check-ups.

· Cloudigo App.

· Gym and Spa discounts.

· Mental Health Programme.

· Continuous opportunity for professional growth and training.