Position : Filling Line - Technical Lead (Deputy Manager)
Location : Hyderabad
Company : MNC Pharma manufacturing Sterile injectables
Qualification : Bachelors Degree in Technology / Engineering
Experience : 10-12 years experience in Sterile manufacturing with Isolator technology in a Pharma industry. Roles & Responsibilities: Responsible for Process equipment in filling Area (Complete Filling Line, Component Processor, Autoclave, Glide Force Testing Machine and other Misc. Equipment)
Responsible for installation & commissioning activities & shall co-ordinate with OEMs for all technical resolutions.
Responsible to execute all qualification activities inclusive of OQ and to support during PQ.
Ensure closure of majority of tasks concerning inspection, fault finding, and maintenance of process equipment in line with APU objectives.
Ensure facilities operational conditions, safety, GMP compliance, and asset protection in order to satisfy internal customers.
Develop and review technical documentation URS, FAT, SAT, IQ and OQ, lead to participate and execute commissioning and qualification in all developmental projects
Ensure closure of all QMS activities in timely manner related to process equipment is to close in time like Phenix, Geode+ etc.,
Develop/Review and establish equipment maintenance SOPs.
Any other tasks / jobs assigned from time to time by Head process maintenance and head engineering.
Responsible for Spares, consumables, preventative & breakdown maintenance
Ensure execution of preventive maintenance for all process equipment as per approved PM plan.
Receive work order, ensure completion of work order and report the same.
Manage (Develop, plan, review, indent and procurement) requirement of all spare parts and consumables to ensure equipment / facility availability all the time and to avoid down time for want of spares.
Ensure maximum availability of equipment and facility for higher productivity and optimum utilization & support equipment uptime /OEE.
Ensure that equipment breakdown attended promptly. Repetitive failures are analysed and corrective actions implemented to avoid the same in coordination with team.
Ensure that all maintenance and engineering activities are carried out in safe and in compliance with GMP / establish procedure.
Identify, evaluate, plan and execute actions and suggestions which improve productivity, safety compliance and help in resource /energy conservation.
Plan & develop OPEX budget for maintenance activities in coordination.
Coordinate with OEM for resolutions in case of any complex challenges.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Production, Manufacturing, Maintenance
Role Category: Production/Manufacturing/Maintenance
Role: Quality Assurance/Quality Control Manager
Employment Type: Permanent Job, Full Time