Documentation

Job Description

Job Title:  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

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