Key Duties and Responsibilities:

Supervision

• To conduct environmental monitoring of the clean room and inform the maintenance department in case of any deviations.
• To supervise cleaning and disinfection of the clean room as per SOP.
• Report any maintenance work in the clean room to the maintenance department.
• To ensure the availability of a sufficient number of garments in the clean room.
• To do routine checks on the cleanliness of workers inside the clean room area.
• To ensure that all cleanroom staff adhere to proper gowning procedures of the cleanroom as per SOP.
• To supervise and monitor the standards of hygiene and cleanliness in the dispensing area all the time.
• Check inventory levels of materials required. That is cleaning agents, gloves, etc.
• To ensure that SOPs are followed in the process flow of water treatment.
• To enforce cGMP guidelines and ensure their implementation in the water treatment plant.

Process control

• To fill BMR requisition upon receipt of the production plan and send it to the QA department for BMR registration.
• To get BMR approved with authorized signatures.
• To take store requisition slips from the BMR and get authorized signatures.
• To make the required equipment available in advance, which is necessary for dispensing, like sterilized scoops, double plastic bags, and cable ties.
• To give proper identification tags on issued material in the dispensing area.
• To weigh and issue the correct quantity of raw materials and balance calibration in the dispensing area.
• To monitor positive pressure and temperature/humidity of the dispensing area and inform the engineering department if any abnormality is found.
• To check the cleaning of dispensing booths and scoops after the dispensing process.
• To return excess raw and packaging material after completion of dispensing to store using a return slip.
• To receive plastic granules for daily manufacturing activities and its accountability.
• Checking and filling of batches online for proper production planning and accountability.
• To transfer dispensed raw materials to the mixing area, use the pass box for batch manufacturing.
• To ensure that batches are manufactured on time as per the SOP.
• To ensure that CIP/SIP processes are undertaken as per validated procedures.
• To do filter intensity tests on both air and product filters as the SOP.
• To start and stop production filling lines.
• To ensure smooth functioning of the water treatment plant.
• To liaise with the team leader in case of any maintenance works.
• To ensure a constant and even supply of quality RO water and WFI to all points of usage.
• To ensure that all equipment undergoes routine validation and calibration processes.

Documentation

• To do online documentation.
• To ensure that all BMR records are properly filled on line.

Any other Duties

• Ensure that any other duty assigned by HOD is executed to management expectations.

• AUTHORITIES:

  • Operate water treatment plant equipment.
  • Perform chemical cleaning of the plant and maintain it in good working condition.
  • To weigh and issue the correct quantity of materials to the clean room and do balance calibration in the dispensing area.
  • Do raw materials requisition from the stores and give its accountability.
  • Manufacturing of product batches.
  • Verification of cleanliness of the cleanroom and proper gowning of cleanroom personnel.
  • Monitoring of manufacturing process.

   

  Qualifications, Skills and Experience:

  • Bachelor’s degree in industrial chemistry or any chemical related course
  • 2 years’ experience working in relevant/similar company

  Competencies:

  • Technical Knowledge/Skills:
  • Report Writing Skills
  • Analytical Skills
  • Presentation skills
  • Good communication & interpersonal Skills
  • Computer Skills (PPt, Excel and MS Word)
  • Able to learn and adopt to change.
  • Innovative/creative skills.

  Behavioral/Attitude Competencies:

  • Respect for others
  • Sociable
  • Result oriented
  • Open and Decisive.
  • Business Acumen
  • Teamwork
  • Responsible
  • Mature & assertive

  TRAINING REQUIREMENTS:

  • Basic safety training
  • Basic GMP training
  • Leadership training
  • Entry & exit into production area training
  • Good documentation practices training
  • Hygiene training