Job Qualifications;

- Graduated from Pharmacy, Chemical Engineering, Chemistry or Biology Departments of universities,

- Advanced level of proficiency in English (reading, writing and speaking),

- A total of 8 years or more of managerial experience, at least 5 years of which must be in sterile / aseptic human pharmaceutical production processes,

- Experienced in vial and disposable syringe filling - preferably lyophilisation - operations,

- He/she has a good command of EU GMP practices and preferably has experienced the process from end to end,

- Managerial competencies to organise a team or an established team,

- Prone to teamwork, strong communication skills,

- Class B driving licence, able to drive an active vehicle,

We are looking for a "Production Manager".

Job Description;

From the management of the production plan and its timely organisation and control according to market demand,

From the control and statistical analysis of progress, product, quality and production cost on a monthly basis,

According to the production plan, checking whether the material is sufficient and checking the material requirement plan to ensure that production is carried out in an orderly manner,

Review of GMP documents such as product release application, product transfer application and non-conforming product destruction application (conformity, consistency checks),

Evaluation of the existing process, continuous optimisation of process documentation and operating procedures,

According to the production demand, from designing the organisational structure of the Production Department and controlling the training of the relevant personnel, the signing of the personnel's job responsibilities,

Regular control of critical process points, parameters, SOP implementation and management at production sites according to approved documents,

Inspecting and correcting defects detected in the field,

Operation, cleaning and daily maintenance management of the equipment and facilities used in the Production Department, control of the calibration plan of equipment and vehicles, approval of purchase requests,

Review of the validation plan of the Production Department,

Controlling the validation protocol and report and supervising the implementation in the Production Department,

From deviation management in the Production Department, control of deviation reports and finalisation of applications,

Responsible for change management, review of change practices, risk assessments, action plans and implementation of changes in the Production Department,

Regular assessment of potential risks to Production Department equipment and processes,

External audit, internal audit and initiating CAPA according to deviation and reviewing the reports of each stage of CAPA,

will be responsible for the main issues and operational requirements.