Formulation & Filling Manager - Talent Pooling

Biovac; Cape Town; On-site; ZAR 900,000 - 1,200,000; Full time

Job summary

Biovac is seeking a qualified production leader to ensure all activities and facilities meet GMP, QA and regulatory standards. The role requires collaboration across safety, quality and production areas, with focus on continual improvement, documentation, and training.

You will oversee department budgets, production planning, and performance management while mentoring supervisors and staff in a fast-paced manufacturing environment.

Qualifications

• Requires relevant tertiary qualification.
• Bachelor’s degree in Health Sciences or Engineering preferred.
• At least 3 years’ experience in cGMP pharmaceutical manufacturing environment.

Responsibilities

• Ensure safety in the department and promote safety metrics.
• Ensure production activities comply with GMP, SOPs and QA requirements.
• Manage department performance and review batch records.
• Develop and execute departmental training programmes.
• Drive continuous improvement of processes and documents to meet regulatory standards.
• Lead cost management and production budgeting within the department.
• Oversee departmental project development and production plans.
• Coach Supervisors and staff; manage talent development and succession.

Skills

cGMP experience in pharma

Management experience

Production/ manufacturing exposure

Aseptic manufacturing

Regulatory audits knowledge

Pharmaceutical legislation awareness

Education

Relevant tertiary qualification

Bachelor’s degree in Health Sciences or Engineering

Job description

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.

Requirements

Required

• Relevant tertiary qualification

Preferred

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

Experience & industry knowledge

Required

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

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

Preferred

• 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.

Responsibilities

Safety Deliverables

• 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.

Quality Deliverables

• 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.

Production Deliverables

• 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.

People Management

• 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 & development to ensure technical and leadership bench strength within the section

• Ensure accurate and documented delegation of ongoing operational activities in the event of key staff members’ absence in line with the related policies and SOP’s

• Develop and sustain the required organisational structure within the Department

• Develop and maintain individual development and growth plans as well as adequate performance management.

Cost Deliverables

• Responsible for the development and maintenance of the department budget

• Responsible to identify and implement cost savings within the department

• Responsible to evaluate the need for capital expenditure together with respective business cases

• Responsible for inventory management within the department.

Business Management

• Shared accountability for achieving the site’s tactical plans and mitigation of any risk to the site operation including workflow, ethics, quality, finances, regulatory compliance and other material company requirements

• Identify and continuously present key opportunities and synergies that will improve and/ or expand the operation within own and/ or other sections

• Lead or participate in section and/ or site wide projects

• Lead own section’s transition into commercial operations and mind-set as well as managing efficiencies, reducing wastage and contributing to overall profitability.

Technical Competencies

• Processes Development and Review

• Intermediate proficiency in Microsoft Word, Excel, Power point and Project

• Metric & KPI development

• Technical Report Writing

• Operational Costing & Budgeting

• Statistical Literacy

• Coaching & Mentoring of peers & staff