Job Description
Job Title:  Manager - Documentation

Job Responsibilities: -

  • Complete documentation in-charge / lead for all three manufacturing sites, Water System, HVAC, Nitrogen Dry Air, Breathing Air And Statutory Compliance in-line with audits compliance (Regulatory / Customers). 
  • Reporting to the Head of Plant Engineering.
  • Assists the Head of Plant Engineering in planning and scheduling project works, preparing and reviewing of specifications for new equipment, and ensuring its proper installation and commissioning.
  • Assists the Head of Plant Engineering in implementing capacity expansion projects within the plant as required.
  • Responsible for monitoring the internal and external calibration of various measuring equipment and recording apparatus.
  • Responsible for conducting routine inspections of the plant to identify defects and guide staff in resolving plant maintenance issues.
  • Responsible for generating Standard Operating Procedures (SOPs) related to maintenance.
  • Assists the production department in maintaining cGMP (current Good Manufacturing Practices).
  • Trains department employees periodically to ensure effective operations.
  • Responsible for updating Standard Operating Procedures (SOPs) periodically.
  • Responsible for overall Quality Management Systems (QMS) related to plant engineering.
  • Responsible for overall electrical and instrumentation-related maintenance of the plant.
  • Responsible for carrying out operations as per standard operating procedures related to power.
  • Ensure implementation of documentation as per the EHS guidelines ISO14001/OHSAS18001.
  • Preparation of budget data and cost estimations.
  • Preparation and review of SOPs, protocols, formats, and department manuals as per the plant equipment requirements.
  • Ensure implementation of calibration of instruments (analog and digital) as per the prescribed schedules.
  • Ensure preparation and review of master equipment lists and instrument lists in the plant as per procedures.
  • Ensure implementation of building and facilities maintenance, including annual and routine painting, as per prescribed schedules and procedures.
  • Preparation and review of drawings for all modifications and submission for approval by statutory and local authorities.
  • Preparation and review of plant and equipment layouts for documentation requirements.
  • Ensure implementation of instrumentation, electrical, and utility AMCs as per schedule.
  • Ensure annual certification of pressure vessels, tools, and tackles by the authorized agency of the Factories Department, Telangana.
  • Ensure annual inspection of electrical installations by statutory authorities as per IER.
  • Ensure calibration of storage tanks and certification as per the schedules and statutory requirements by the Department of Legal Metrology, Telangana.
  • Ensure calibration of weighing balances and dead weights, and certification/stamping as per the schedules and statutory requirements by the Department of Legal Metrology, Telangana.
  • Responsible for maintaining documentation in the entire department as per GMP requirements.
  • Maintenance of fixed assets documents and registers.
  • Any unplanned work related to plant engineering not covered in the above points.

 

 

Job Requirements: -

Must Haves: -

  • B. Tech Graduate in Mechanical Engineering.
  • 12 + years of experience in a documentation role in Plant Engineering for a Pharma API Manufacturing Company.
  • The candidate should possess good knowledge and experience working with: - o Water System o HVAC
  • Nitrogen o Dry Air System o Audit Compliances
  • Plant Maintenance/ Qualifications o Statuary requirements