Production Supervisor Medicine (Liquid/Oral)

Geltec Private Limited; Bengaluru; On-site; INR 600,000 - 800,000; Full time

Job summary

Geltec Private Limited in Bengaluru, Karnataka, seeks an experienced Production Supervisor for the Medicine Department to supervise the execution of the Production Plan, guide and develop operators, and ensure delivery of quality medicines in compliance with GMP and SOPs.

You will train and motivate teams, manage shift operations, oversee BMRs and logs, coordinate with other departments, and maintain readiness for internal or external audits.

Qualifications

• Pharmacy/BSC/MSC graduate with relevant degree.
• 4–10 years of pharmaceutical industry experience.
• Strong knowledge of processes, equipment, systems and SOPs; good communication and interpersonal skills.

Responsibilities

• Report and discuss issues or non-compliance with the department manager and head of department immediately.
• Follow the Monthly/Weekly/23 days Working Plan and prioritize actions for implementation.
• Plan and arrange materials, medicine and manpower to implement Daily Production Plan per shift.
• Ensure allocation of manpower and inputs to start work per shift after line clearance.
• Monitor productivity and quality through in-process checks and critical parameters.
• Monitor yield, reduce wastage and carry out troubleshooting as required.
• Attend breakdowns and plan alternative activities when needed.
• Handover shift to the next supervisor with proper shift log.
• Act as Shift In-Charge in 2nd & 3rd Shift.
• Prepare Daily/Weekly/Monthly Production Reports as applicable.
• Carry out online BMR entries, logbooks and BMR reconciliation.
• Maintenance of M/c Log, Temperature RH Report.
• Prepare SAS requisition of medicine as per BMRs to QC/QA.
• Maintain calibration records, housekeeping records.
• Maintain machine spare parts for equipment.
• Know staff capabilities and ensure GMP compliance in dress code, PPE, etc.
• Document operations and cleaning in logbooks; keep area clean.
• Ensure room temperature and RH are maintained per BMR and updated.
• Provide on-the-job training to operators and casual workers; act as mentor.
• Maintain good interpersonal relationships with seniors, peers and subordinates.
• Handle leave planning, absenteeism and misconducts.

Skills

Process knowledge

Equipment knowledge

SOPs

Communication skills

Interpersonal skills

Education

Pharmacy Graduate

BSC Graduate

MSC Graduate

Job description

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.