Team Lead- Engineering Documentation

1 week ago

Hyderabad, Telangana, India Dr. Reddy's Laboratories Full time

Job Description

Roles & Responsibilities

  • To implement GDP as per the Company's Quality policy for ESD.
  • To ensure that compliance (regulatory, statutory and legal) is understood, implemented and monitored on daily basis.
  • Preparation and updating of Job descriptions & organogram of ESD.
  • To ensure that the new SOPs, CCFs, Validation protocols, reports (like qualification) etc. (with the support of related peers) are prepared and reviewed and implemented on time as per the ESD objectives.
  • Preparation of Equipment qualification protocols and reports. Ensuring timely completion as per schedule.
  • Preparation of SOPs and ensuring periodical review.
  • Initiating ESD CCFs, IRs, Tracking and closure of CCF, IR and CAPA of ESD.
  • Incident investigations and finding root cause of failures with appropriate CAPA.
  • To provide Audit support, response & tracking.
  • To prepare updated plant layout and P& ID diagrams.
  • To ensure maintaining the records on history of equipment at the site.
  • To ensure timely documentation as per SOP.
  • Making of routine trends, reports, receipts. etc for the ESD department.
  • To be involved in pre-audits (relevant to ESD).
  • To be involved and ensuring training of ESD personnel as per the site objectives.
  • To provide Induction training for new employees.
  • Ensure Preventive maintenance of production area and ZLD area instruments.
  • Preparation of Preventive and facility maintenance schedules and ensuring completion as per schedule.
  • Preparation and tracking of ESD related schedules.
  • To maintain records/ documents as per SOPs.
  • Ensure that the equipment and related systems (both old and new) are (re)qualified / (re)validated as per schedule.
  • To ensure cGMP implementation in his/her area as per the QMS.
  • Ensure the good housekeeping as per site objectives.
  • To meet SHE targets for their area.
  • You will be responsible for reviewing engineering deliverables and extending appropriate corrective actions to attain excellence.
  • Your role includes guiding team in closure of event investigation, proposing proper CAPA (Corrective and Preventive Actions) and ensuring audit compliance.
  • You will be responsible for handling projects related to machine upgradation, installation and commissioning of new equipment, and area modification.
  • You will also manage interactions with vendors, cross-functional teams, regulatory teams and internal audit teams.
  • You will be responsible for providing inputs and responses fore deviations and observations during internal audits and inspections.

Qualifications

Educational qualification : A bachelor's in engineering (Mechanical Engineering or Any other Discipline)

Minimum work experience : 5 to 10 years

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