Post Production - Executive (Softgel Capsules).

JOB PURPOSE:

Plan, supervise and execute of Postproduction plan for the post production department as per BMR/BPR and SOPs to meet site dispatched schedule.

2. KEY RESULT AREA:

• Supervision and Plan Execution: - To ensure of daily plan to deliver agreed Dispatch of the product.
• Documentation: - Online documentation of BMR/BPR and logbooks as maintained in the departments.
• Man Management: - Ensure training and development of Operators and Temporary Employees, guide and motivate to prepare competitive teams in the department.
• GMP and Quality Compliance: - Achieve high quality products through regular monitoring, guidance and implementation of GMP compliances and other policies, Sop's, policies and systems are to ensure committed products are delivered on time.
• Employee Relations: - Maintain a high standard of discipline in the department.

3. KNOWLEDGE / EXPERIENCE / SKILLS REQUIRED:

KNOWLEDGE: Pharmacy Graduate/BSC Graduate/MSC Graduate.

EXPERIENCE: 24-year experience in Pharmaceutical Industry.

SKILLS: Must possess good knowledge of process, equipment, systems and SOPs, and Should have good communication skills, Interpersonal Skills.

4. PRIMARY RESPONSIBILITIES:

• Sufficient knowledge of products, procedures, SOPs, Processes, Systems and practices related to the department functions.
• Co-ordinate with cross-functional department for validation & qualification activities.
• Be aware of weekly / 2–3 days Working Plan for the postproduction department and prioritize inspection plan to meet packing requirements. Plan and arrange materials and manpower to implement Daily postproduction plan in the Department / Shift.
• Ensure allocation of Manpower and availability of inputs to start the work in the Department / Shift correct time after obtaining necessary QC clearance.
• Monitor productivity and ensure proper inspection of Capsules/Soflet.
• Carry out in process check as required and prepare pending list for QC to prioritize analysis.
• Monitor yield and carry out trouble shooting as required.
• Attend breakdowns and plan for alternative activity when required.
• After Inspection bulk samples shall be submitted for QC analysis as per requirement.
• To coordinate with QC and packing department to meet the packing requirement.
• Ensure On-the-job Training of Executives, Operators and Temporary workers and act as Mentor.
• Maintain Good Interpersonal Relationship with seniors, Peers and Subordinates.
• Maintain Shop Floor Discipline, Solve Routine Problems and handle Grievances proactively through counseling.
• Maintain a high level of staff motivation through recognition, rewards and reprimand when required.
• To understand company's business and have knowledge of products, SOPs, processes, systems and practices related to the department functions.
• Monitoring and control of manufacturing environment.
• To understand Monthly / yearly Manufacturing Plan of the company, prioritize and monitor preparation of Weekly/Daily Manufacturing and packing Plan to meet scheduled deliveries.
• Plan and monitor arrangement of inputs, materials and manpower in the Department.
• Monitor allocation of Manpower and availability of inputs and ensure the work in the Departments starts on time. Plan and execute alternative plans in case of exigencies.
• Ensure prevention of breakdowns through preventive maintenance & liaison with Engineering Department.
• Liaise with other departments to solve bottle necks and other problems.
• Ensure that products are manufactured, packed and stored according to the product requirement to obtain the required quality.
• Ensure completion and accuracy of BMR Entries, authorize deviation where required and complete documentation in time.
• Review and maintain the production batch manufacturing records.
• Monitoring of storage condition for materials and products.
• Balance calibration record shall be maintained as per SOP.
• Ensure Date authenticity and Data Integrity.
• To approve the instructions relating to production operations and ensure implementation.
• Ensure that timely effective communication and escalation process to raise quality issues to the appropriate levels of management.
• Ensure cGMP compliances in all respect of dress code, wearing of jewelry, haircut, nail polish etc.
• Ensure proper door culture and implementation of Personal Protective Equipment Policy.
• To ensure that products are produced and stored according to the appropriate documentation to obtain the required quality.
• To review system and gaps during routine activity and provide inputs for improvement.
• Compliance with entry and exit procedure.
• Compliance with the procedure for operation and cleaning of equipment's.
• Compliance in inspection, polishing and printing activity of capsules or Soflet as defined in BMR and SOP.
• Document the operation and cleaning of machines in logbooks.
• Ensure that Polishing bags are stored in proper manner as defined as per SOP.
• Bulk packing and inspection activity shall be carried out as defined in BMR.
• After Inspection bulk capsules and Soflet to be stored in respective storage area as defined in SOP.
• Monitor the environmental condition of tunnel dryer.