Ffp Production Manager - Wildlife Pharmaceutical'S

Trending Talent Solutions; Mbombela; On-site; ZAR 500 000 - 700 000; Full time

Job summary

A pharmaceutical manufacturing company based in Mpumalanga is seeking a qualified Production Manager to lead a dynamic team in the production of sterile pharmaceuticals. Responsibilities include managing the entire sterile production process, ensuring compliance with GMP standards, and optimizing workflows for maximum efficiency. Candidates must have a BPharm degree and at least 3 years of GMP production experience. This role is essential for maintaining high-quality standards and effective team management within a sterile environment.

Qualifications

• Registered as a practicing pharmacist with the SAPC.
• Minimum 3 years' GMP production experience including aseptic sterile manufacturing.

Responsibilities

• Manage the FPP production team to achieve operational excellence.
• Ensure compliance with regulatory requirements.
• Optimize production processes to improve efficiency.
• Oversee inventory management for production needs.
• Conduct audits and maintain records for compliance.

Skills

Leadership skills

Effective communication

Knowledge of GMP regulations

Organisational skills

Analytical thinking

Clear documentation

Education

BPharm degree

Job description

Role Purpose

To orchestrate and lead a dynamic team in the production of high-quality sterile pharmaceuticals that meet or exceed GMP standards, ensuring the utmost safety, efficacy, and compliance.

To oversee and optimise the entire sterile production process, from raw material receipt to final product release, with a relentless commitment to maintaining sterile environments and upholding the highest standards of quality assurance.

Required Role Qualifications

BPharm degree, registered as a practicing pharmacist with the SAPC.

Minimum 3 years' GMP production experience including aseptic sterile manufacturing.

Required Role Skills and Abilities

Strong leadership skills & effective communication to manage and motivate a diverse team.

Knowledge of GMP and other industry regulations.

Organisational skills to manage production schedules and meet deadlines.

Efficient resource allocation and budget management.

Clear documentation and reporting skills.

Excellent understanding of pharmaceutical manufacturing processes and equipment.

Analytical and critical thinking skills to address production challenges.

Role Responsibilities

Leadership & Team Management

Inspire, lead, and manage the FPP production team to achieve operational excellence.

Foster a culture of accountability and continuous improvement.

Provide clear direction, coaching and mentorship to team members to encourage collaboration and create a high-performance work environment.

Take responsibility for the sterile production area, equipment, operations, and records.

Oversee day-to-day manufacturing operations and identify the resource requirements of the sterile facility.

Manage resources effectively, including personnel, equipment, and materials.

Collaborate with cross-functional teams to streamline workflows, minimise downtime and enhance overall production capabilities.

Communicate effectively with cross-functional teams, providing updates on production status, challenges, and achievements.

FPP Production Planning & Optimization

Develop & execute production schedules that align with organisational goals, planning & prioritising production activities in line with business needs.

Communicate production goals, targets, and plans timeously with all FPP Production personnel.

Ensure efficient allocation & utilisation of resources while maintaining compliance with regulatory requirements.

Develop and implement robust contingency plans to address unexpected challenges in production, ensuring minimal disruption and maintaining product integrity.

Continuously identify opportunities for process improvement.

Implement lean manufacturing principles to enhance productivity and reduce waste.

Continuously evaluate and optimise manufacturing processes to improve efficiency, yield, and quality and reduce waste.

Inventory Management

Monitor & maintain adequate inventory to meet production needs.

Manage procurement of raw materials, primary packaging, consumables etc. ordering timeously in line with established lead times.

Establish efficient inventory control in collaboration with the W&PO to prevent shortages, expiry, and overstocking.

Ensure materials in the production facility are used for the intended purpose for which they were issued.

Manage the handling, storage & recording of bulk API and API / FPP retention samples.

FPP production operations

Oversee execution of the production plan as scheduled and within predetermined timelines.

Efficiently manage resources, including personnel, equipment, and materials, to meet production schedules while maintaining cost-effectiveness.

Proactively identify and address potential bottlenecks or resource constraints to ensure seamless production flow.

Oversee the manufacturing process to ensure adherence to cGMP and aseptic techniques.

Ensure products are manufactured in accordance with the appropriate master record.

Manage Schedule substances in the sterile production facility as per relevant SOPs and regulations.

Verify the cleaning status of rooms and equipment.

Review & approve verification of measuring equipment.

Authorise line opening and closing activities.

Independently check & sign for each dispensed material.

Supervise and verify the addition of each material during compounding.

Verify the identity of bulk product and conduct intermix checks to assess uniformity.

Verify printed packaging material details.

Verify IPCs are in line with specified product quality and specifications.

Verify all calculations performed.

Perform and review shift GMP compliance checks during production & communicate findings with the relevant department.

Troubleshoot and resolve issues that may arise during production.

Take responsibility for batch reconciliation and investigation of non-conformances.

Review batch records for completeness and accuracy at the end of shift.

Review batch records and supporting data, addressing any discrepancies / issues identified before performing final sign-off on batch records for submission to QA.

Execute and oversee technology transfers and process validation activities, including review of associated documentation.

API Production Operations

Perform and / or oversee line opening and closing.

Approve the end of batch reconciliation once API is sampled and packed.

Receive bulk API and API retention samples from the API production area for storage in the warehouse.

Waste Management

Stay informed about regulations regarding the disposal and destruction of waste.

Compile / review and maintain the relevant waste management SOPs and regularly audit the company's waste management process.

Ensure production waste is appropriately handled and segregated.

Receive and manage QC samples returned for destruction by contract laboratories.

Ensure production waste is stored safely and securely before dispatch for destruction.

Review production waste logs for accuracy and completeness.

Maintain accurate records of production waste for compliance and audit purposes.

Submit consolidated Schedule 5 / 6 waste information to the RA Manager to obtain SAHPRA permits for destruction.

Take responsibility for the relationship and communication with the approved waste disposal service provider.

Participate in or conduct regular audits of the approved waste disposal service provider.

Train personnel on proper procedures for handling of production waste.

Management of Facility, Equipment & Sterile Environment

Oversee the design, implementation, and maintenance of sterile manufacturing environments.

Monitor and maintain equipment used in the sterile facility, ensuring proper calibration, validation, and preventative maintenance.

Regularly review facility & equipment checks completed by FPP Production Operator / Assistant

Verify, review, and approve verification of equipment performance.

Monitor cleaning of the sterile facility / equipment and ensure adherence to aseptic processing principles and contamination control measures.

Participate in the implementation and management of environmental monitoring programmes to assess & control microbial & particulate cleanliness of the cleanroom facilities.

Perform regular self-inspections to identify and address potential risks to product sterility & cGMP compliance.

Documentation

Implement & maintain good document practices as per sitewide QMS.

Manage the compilation & review of relevant SOPs and work instructions, as required.

Compile / review URSs and qualification documents for production the production facility / equipment / utilities.

Review logs generated by the FPP production facility e.g. cleaning logs, equipment logs, etc.

Review master batch documents and request and / or review updates as required.

Review and approve batch records to verify the accuracy and completeness of production documentation, ensuring all steps are executed according to established procedures.

Maintain accurate and detailed records of production activities, QC checks and other relevant information.

Address and resolve batch document queries received from QA.

Training & Development

Ensure the FPP production team is adequately qualified and trained to perform their duties.

Mentor and support the professional development of junior personnel.

Train and supervise FPP production personnel on cGMP, new processes (incl aseptic technique), equipment, and safety protocols.

Perform and / or coordinate the training of FPP production personnel on relevant SOPs / work instructions and associated task observations.

Verify that contractors / non-production personnel entering the production facility are appropriately trained and gowned.

QA and Compliance

Stay up to date with regulatory requirements, upholding rigorous quality standards.

Maintain a relentless focus on compliance with cGMP & internal QMS.

Collaborate closely with QA to implement & maintain robust quality systems.

Lead investigations into quality incidents e.g. deviations, non-conformances, OOS, risk assessments etc. and ensure timeous compilation and submission of reports & supporting documents.

Oversee / manage timeous implementation of corrective & preventive actions.

Participate in internal and external audits to ensure cGMP compliance.

Ensure FPP facility audit findings are addressed and effectively corrected within the required time.

Compile and present PQR data and reports for FPP manufactured.

Technology Implementation and Innovation

Stay abreast of industry advancements, emerging technologies, and best practices to drive innovation in the sterile production facility.

Evaluate and implement cutting-edge technologies that align with the organisation's strategic objectives and enhance efficiency, quality, and sustainability within the manufacturing environment.

White River

Published Date: 02 December

Closing Date: 31 January