Job Purpose :
To assist Production Lead in responsibility to manufacture of all products in both Toiletries and Healthcare consistent with scheduled requirements, cost, safety, Environmental and Quality standards.
Responsible for ensuring compliance with all regulatory aspects of the manufacturing and filling of registered Pharmaceutical Products.
Responsible for managing production personnel to maximize quality and output in a manufacturing operation.
Accountable for achieving production targets while maintaining cost controls.
Form, lead and develop the shift team on his / her shift to meet goals and objectives of the department in terms of safety, quality, housekeeping, cost and line throughput.
The team consists of the following members :
In-Process Quality Controllers (IPQC)
Mixers & Weighers
Ensure that all employees are adequately trained for the jobs I tasks they are required to perform.
Build and maintain close collaboration with technical support personnel and ensure timely support when problems occur.
Effectively collaborate with other areas such as Planning, RMS, EHS, HR and QA to guarantee a flawless operation and ensuring that agreed standards are always met.
Collaborate extensively with the other Production shift teams
Champion assigned Continuous improvement programs and deliver on targets
Actively manage financial indicators such as overtime spend, casual utilization and operating supplies.
The main duties and responsibilities of the position are :
Ensures that all active raw materials' potencies are correctly calculated and that all raw materials are accurately weighted or measured and differences rectified prior to mixing.
The production pharmacist must supervise all additions and returns of active ingredients used in registered products. Complying with Regulatory Standards.
Ensures that every addition of material to the mixing vessel is checked and signed for by competent personnel, and that no unauthorized deviations from the method and formula take place.
In that when authorized are necessary, these are recorded on the relevant documents.
Ensures all standards of the product are adhered to, and that pH and / or Viscosity are checked, rectified and signed for by competent personnel.
Oversee adjustments and give assistance.
Ensures that final mass or volume checks are carried out before filling of registered products proceeds. Mass checks are to be carried out and recorded on documents with an authorized final yield reconciliation statement.
Authorizing filling of product prior to line start-up.
Ensures all people and products are protected from each other by using specified protective clothing and equipment and that all staff is protected against potential accident and health hazards.
Complying with corporate and regulatory SHE and GMP requirements.
Ensures Regulatory and Company compliance. Ensures that all company rules and regulations regarding accident prevention, fire precaution and good housekeeping are complied with always.
Responsible for ensuring that overall production meets legal requirements of MCC. Ensues that packaging is correctly applied (Inner, outer, labels, package insert) and complies with relevant MBR specifications.
No major non-compliances when audited by regulatory authorities.
Ensure that employees are trained and competent to perform job functions. Train new mixers on applicable Wl's. Arrange for appropriate training to be executed to ensure staff are competent.
Multi skill mixers across mixing functions to ensure continuous production. Complying with corporate and regulatory SHE and GMP requirements.
Supervise and direct Chemical Engineering Graduates in their capacity as Technical Mixers. Ensure that graduates are placed within the correct team to be able to impart knowledge to uplift current skills level.
Ensure Graduates are trained for lob specifics and are capable to carry out specific tasks. Give guidance where and when necessary through assigning small projects to Individuals.
Assess output by observing graduates’ on-the-job functions.
Supervise and direct Technical Mixers in their capacity as Pharmacists' Assistants. Ensure that Pharmacist's Assistants are placed within the correct team to apply pharmaceutical knowledge.
Ensure that PA's are complying with rules and regulations for PA's as stipulated by Pharmacy Council. No major non-compliances when audited by regulatory authorities.
Supervise and direct Technical Mixers in their capacity as Mixers. Ensure that Mixers are placed within the correct team to apply their knowledge and skill.
Ensure that Mixers are complying with rules and regulations for GMP as stipulated for the manufacture of Pharmaceutical products.
No major non-compliances when audited by regulatory authorities.
Ensuring that housekeeping and safety standards are well defined and are always met. Train team members accordingly. Conduct regular, documented inspections and involving other members of the team.
Seek support from EHS or other functions when needed.
Carry out regular quality checks; ensure that operators fill in required documents correctly. Work closely with quality personnel and ensure proper and immediate reaction on any quality deviations.
Organize regular communications on quality results achieved.
Ensure that operational targets are met for line output (OEE), waste and cost for your shift.
Lead the target setting process together with key operators of the team.
Plan suitable staffing for the lines; ensure that skill distribution per line is planned appropriately both for regular operating times and overtime on weekends.
Guarantee that labor regulations are always met, specifically for overtime.
Conduct disciplinary enquiries and counselling if required.
Develop skills and ability profile for each job and compare the actual status for each operator. In addition, develop a gap analysis and organize trainings to close the gaps.
Conduct regular performance appraisals for the staff. Establish development plans for each individual team member.
Ensure that all required operational parameters are set as agreed (i.e. line speeds, detector functions) and ensure that the required documentation is reported correctly, i.
e. Shift report, Downtime report, Batch records, etc. Deliver detailed information on major problems; include material samples, pictures and detailed issue description.
Follow escalation protocol and procedure to escalate issues to the management of the area.
Ensure ongoing effective communication to the teams and utilizing regular shift meetings.
Facilitate effective shift handover process for each shift (shift report)
Prepare for and manage the daily Production meetings when on morning shift (incl SDAC).
Participate and contribute in weekly and monthly departmental meetings.
Demonstrate sense of urgency in pulling the right resources once machines are down (maintenance / engineering / QA / material planners, etc.)
Ensure that right materials are available. Keep material inventories in the area at acceptable levels and ensure FIFO principles
Contribute to improvement projects
Effective management of changeovers and stock take processes
Effective time and attendance management.
Establishes personnel schedules and product lines based on business needs.
Provides input to production flow and identifies potential manufacturing issues.
Tracks production orders and schedules.
Compiles and submits data for production and operating reports.
Trains staff in the areas of safety and quality.
Reviews work to ensure compliance with the standards.
Schedules or performs training for all employees.
Recommends changes to standard operational and working practices.
Educates employees and observes to ensure understanding and compliance.
Provides input to operational budget.
Manages costs to improve business' financial results.
Administers equipment maintenance and repair.
Maintains records and notifies management of reoccurring issues that may require equipment replacement
Responsible for the implementation of SANS 1841 requirements in the Manufacturing departments.
Qualifications We’d love to hear from YOU, if you have :
Matric with B Pharm / Dip Pharm.
Completed Internship with experience in a Manufacturing Environment.
Ability to lead teams
Good Technical understanding
Planning and Organising
Good trouble shooting and problem-solving skills
Possessing a "Make it happen" mindset
Effective communication skills
Collaborative approach in managing functional interfaces
Strong result orientation and fact based, and data driven approach
Strong people management skills