Formulation & Filling Manager - Talent Pooling

Job Purpose

To ensure that all production activities and facilities meet the Quality Standards as set out by the Company and Regulatory GMP requirements. To ensure that all relevant production activities are executed efficiently and timeously to meet the Production deliverables as set out by the Company.

• Relevant tertiary qualification

• Bachelor’s degree in a relevant Health Sciences or Engineering field or equivalent

• At least 3 years’ experience in in cGMP pharmaceutical manufacturing environment.

• At least 1 years’ experience at junior to middle management level.

• Experience in a production/manufacturing department

• Experience in aseptic (sterile) manufacturing

• Experience in having faced successful local and/ or international quality audits

• Knowledge of Pharmaceutical Manufacturing related legislation.

• Responsible for safety in the respective Department

• Responsible to ensure that all safety representatives are appointed and present

• Responsible to promote and measure the safety metrics as set forth by the Company.

• Responsible to ensure that all production activities and stages comply with company procedures, policies and regulatory GMP requirements

• Responsible for the department performance against the Quality metrics set forth by the Company

• Responsible for the review and approval of batch records and production related documentation

• Responsible for the development and execution of the departmental training programme(s)

• Responsible for the continuous improvement of processes and documents to meet or exceed current regulatory and GMP requirements

• Responsible to ensure that all processes and equipment’s meet the respective validation and qualification requirements

• Responsible to maintain the production facilities in a state which complies with Company and Regulatory requirements

• Assists in the investigation of incidents that have resulted in non-conforming products, compliance failures or customer complaints

• Assists with the creation and updating of SOP’s and Work Instructions on a continuous basis and ensure the manufacturing and production activities comply with Standard Operating Procedures

• Assists with the creation and updating of batch records on a continuous basis and ensure the manufacturing and production activities comply with Standard Operating Procedures

• Assists with Root Cause Analysis and Risk Assessment activities with the production department.

• Responsible for the delivery of production targets as set forth by the Company

• Responsible for the continuous improvement of processes and documents to meet or exceed the requirements of the Company

• Responsible for the development and sustainment of Departmental performance management systems

• Responsible for the development and sustainability of production activities relevant to the Department

• Responsible for the development and execution of Departmental projects as set forth by the Company

• Responsible for the development, approval and execution of production plans

• Responsible for the development and implementation of routine Departmental activities with regards to the production planning

• Responsible for the management of production routings and the timeously execution thereof

• Responsible for the capacity and utilisation of various production processes or equipment within the Department

• Drives ‘first time right’ execution in all production related activities.

• Role profiling, goal setting and performance management of supervisors and staff within the section

• Growth, succession & retention of talent pools within the section

• Accountability for own and team's personal and professional learning &…