Richard Fernandes

· Management position, designed to supervise and lead a team of employees within a processing site. Includes daily oversight of departmental goals for safety, quality, Customer demands, and operational effectiveness.

· Responsible and accountable for key areas within the site, which will encompass shift Rota planning, organizing, and supervising daily production activities. Liaising with maintenance to make sure plant equipment is regularly inspected, serviced, and maintained in optimal working conditions.

· Will ensure compliant processing of products that adhere to Customer requirements and comply with the company's quality and regulatory standards.

· Involves supervising, training, and developing team members, to ensure work instructions are followed and updated in line with site procedures.

· Responsible for frontline site safety and maximizing plant uptime to ensure Customer satisfaction and site targets are met.

· Lead and develop the relevant operations team daily by conducting a daily process review meeting and a daily shift handover.

· Lead by example, fostering a positive working environment that engages in the continuous improvement of Safety, Quality, Delivery & Cost (SQDC) and Lean principles of continuous improvement.

· Generate and analyse data relating to the performance of the production warehouse and focus on trends, highlighting positives and areas for improvement.

· Ensure site Quality standards are maintained and continually improved.

· Performed quality investigations on non-conformances, including Human error, 5 Whys, and 8 Steps problem solving.

· Products with deviations are reported, quarantined, and clearly identified and investigated.

· Complete Performance Management- annual goal setting & reviews (GPS (Global Performance System)), supervise disciplinary actions

· To complete Labor forecasting, planning, interview/selection, temporary staffing, & Overtime.

• Supervise the on-the-floor operations of manufacturing facility in a cGMP environment.
• Ensuring department outputs (KPI's) are met and that established cGMP quality standards are adhered to at all times.
• Ensure Local ownership and QA track-wise targets are met with timely progression to closure of all deviations, Changes Control, and CAPA.
• To be an effective communication point for the team for all process and business-related information, including MHRA inspections through regular team briefings, etc.
• Work closely with the Training team to ensure that staff training and development are fulfilled, and that training and development records and regular appraisals are reviewed.
• Lead and encourage the team to improve Health and Safety.
• Continuous improvement projects and activities. Identify, communicate, and manage areas for improvement.
• Introduction of new products, equipment, machines, procedures, and processes qualification document (IQ, OQ, PQ) and update SOP with relevant guidelines.
• To recruit, coach, and train team members, ensuring all training plans and assessments are achieved on time
• Manage all aspects of the production planning, including capacity planning, budget, progress reporting, and forecasting.
• Coordinate with supply chain and procurement, and other support functions to deliver 100% schedule adherence.
• Help to ensure that customers, regulatory, quality, and internal requirements are met or exceeded.
• To coordinate and take a hands-on approach to deliver maintenance and calibration plans on time to meet plans.
• Ensuring timely, accurate, and robust investigations are undertaken with respect to Unplanned Deviations, Change Control, and Corrective and Preventive Maintenance Management.
• Allocation of team member duties for shift schedules, overtime assignments, shift rotations, and backup for absent team members.
• Motivate team members and, at the same time, maintain high production and quality standards.
• Operation of SAP and training in Kaizen software.
• Attending daily call meetings, sending/ receiving emails, and authorising annual leave.thetrack-wise,To supervise and lead a team of employees within a processing site, with daily oversight of departmental goals for safety, quality, Customer demands, and operational effectiveness.
• Handling of clinical trial projects.
• Conduct all activities in the absence of the production manager.
• Faced an audit of MHRA with no findings of critical or major points.

· Operation of Automatic Computerised control Machine with Maintenance and Troubleshooting of Compression Machines (B & D Tooling, interchangeable turret) and Capsule Filling machines as per BMR.

· Performing calibration, in-process checks for tablets and capsules, filling as per the Batch Manufacturing Record.

· Inspected finished products for quality and adherence to customer specifications.

• Solid Dosage forms encapsulation, Solid Dosage forms tableting drug.

· Have a Good understanding of 21CFR Part 11compliance and a clear understanding of Data Integrity.

· Having Knowledge of working under other regulatory regimes (US- FDA, MHRA, WHO, TGA).