Production Supervisor Medicine (Liquid/Oral)

1. JOB PURPOSE:

Supervise execution of Production Plan in the Medicine Department by guiding, training & development of department teams with objective of ensuring delivery of products to meet site targets as per BMRs and SOP in compliance with GMP.

2. KEY RESULT AREA:

• Supervision and Plan Execution: - To ensure implementation of Daily Medicine Department Plan in order to deliver quality products to meet agreed production requirements.
• Documentation: - Ensure timely completion of BMRs and other relevant documents to avoid any non-compliance during internal or external audit.
• Man Management: - Ensure training and development of operators and temporary employees, guide and motivate to prepare competitive teams in the department capable of delivering results to meet organizational requirements.
• GMP Compliance: - Ensure implementation of SOPs and Practices to achieve higher GMP Compliances to deliver quality products and prevent Internal or External Audits observations.
• Administration: - Liaise with other departments to ensure availability of various inputs and serviceability of machines to reduce breakdowns / stoppages to minimum.

3. KNOWLEDGE / EXPERIENCE / SKILLS REQUIRED:

KNOWLEDGE: Pharmacy Graduate/BSC Graduate/MSC Graduate.

EXPERIENCE: 4-10 year experience in the Pharmaceutical Industry.

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

4. PRIMARY RESPONSIBILITIES:

• Report and discuss the issues or non-compliance with the department manager and further with the head of the department immediately.
• Be aware of Monthly / weekly / 23 days Working Plan for the Department and prioritize about actions to be taken for implementation.
• Plan and arrange materials, medicine and manpower to implement Daily Production Plan in the Department / Shift.
• Ensure allocation of Man Power and availability of inputs to start the work in the Department per Shift at correct time after obtaining necessary line clearance.
• Monitor productivity and quality of products through in-process checks, and critical control parameters related activity during manufacturing.
• Monitor yield and reduce wastage and carry out trouble shooting as required.
• Attending breakdowns and planning for alternative activity when required.
• Handover shift to the next supervisor after completing shift log properly.
• Act as Shift In-charge in 2nd & 3rd Shift.
• Prepare Daily / Weekly / Monthly Production Report as applicable.
• Carry out online BMR Entries, Logbooks and Reconciliation of BMRs.
• Ensure Maintenance of M/c Log, Temperature RH Report.
• Preparation of SAS requisition of medicine as per BMRs to QC / QA.
• Maintenance of Balance Calibration Records, House Keeping Records.
• Maintain machine spare parts for the equipment.
• Know your Staff and their capabilities.
• Compliance with the instructions given in BMR, SOPs, Process equipment's.
• Compliance with entry and exit procedure.
• Compliance with the procedure for operation and cleaning of equipment's.
• Compliance in manufacturing of medicine preparation as defined in BMR & SOP's.
• Ensure cleanliness of machine and all hose pipes.
• Document the operation and cleaning of machines in logbooks.
• Ensure the work area as Clean.
• Gross weight verification and addition of RM shall be ensured as per BMR and SOP.
• Updating of status label for equipment and area.
• Mesh integrity to be verified before and after usage.
• Ensure that cleaning of tanks and other accessories.
• To carry out in-process checks as defined in BMR and SOP (Ex: Temperature of the medicine during milling, Mixing time, air bubble in medicine etc.,)
• Check the room temperature and RH during the process as per BMR and the same must be updated in BMR.
• Ensure On-the-job Training of Operators and Casuals and act as Mentor.
• Maintain Good Interpersonal Relationship with seniors, Peers, and Subordinate.
• Requisition of Consumables and follow up.
• Handle routine matters on the shop floor such as Leave Planning, Absenteeism, and misconducts.
• Ensure GMP compliances in respect of dress code, wearing of jewelry, haircut, nail polish etc.,
• Ensure proper door culture.
• Ensure implementation of the Personal Protective Equipment Policy.
• Record the entries as per batch documents, logbooks etc. and follow the Good Documentation Practice.
• Report any Open Wounds or Sick or accident immediately to the HR Supervisor.
• To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality.
• Attend the GMP EHS Quality improvement program training weekly conducted by the Management.
• Liaison with other department to gain information, resources and take help for day to day activities.
• Maintain Shop Floor Discipline, Solve Routine Problems and handle Grievances proactively through counseling.