Manager - Commissioning & Qualification - Pharma (Biotech)

Ideal Consultants - Hyderabad
  • Hyderabad
  • 10-13 lakh
  • 10-14 years
  • 13 Feb 2015

  • Production/ Manufacturing/ Engineering

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Candidate should be engineering graduate, with 10 to 14 years of experience in the field of construction, instatallation, commissioning & qualification of facilities, process equipment, CIP/ SIP systems, HVAC, clean&black utilities, piping,electrical & automation systems in GMP environment. Knowledge and experience in pharma and biotechnology particularly in Formulation, Filling and packaging(FFP) IS Preferable.
He will participate/facilitate in execution of FAT, SAT for equipment and startup,commissioning and validation.
He will provide on-site startup, troubleshooting, and engineering services support in co-ordination
He will form the interface with construction contractors, vendors, qulity, engineering and project team,& organizes regular meetings with all stake holders during C&Q phase; he will be responsible for ensuring that works are executed in line with Approved programme All equipment is tested, inspected, and prepared for start-up in collaboration
To conduct pre-startup safety/quality checks/regulatory checks as per protocol/procedures, pre/post inspection checklists/are completed and removed, walk down list is prepared and completed. And facility and equipment are handed over for commissioning.
Develop qualification &requalification plans as per company SOP
Develop PM&calibration plan as per OEM recommendation
Devlop SOPs for O&M, calibration, testing in collaboration & co-ordination
Support & take lead in preparing realistc detailed time schedule for C&Q phase
Ensure that instruments are calibrated
He will support in preparation &execution of DQ/IQ/QQ protocols and final report as per regulatory&Company standard
Assemble and deliver documentation package(qualification and technical)
Routine reporting on progress and any schedule deviations
Perform operations and maintenance training. operating and maintenance procedures should be in place for the facility equipment and systems
Collaborate with plant HSE at site with project activities ensuring all safety and environmental guidelines are adhered during construction and execution

Technical Competencies;
Experience in construction, qualification and validation of pharmaceutical facility& process in necessary.
1.Excellent attitude, attention to detail and interpersonal relationship skills.
2. Excellent documentation practices.
3.Excellent organizational skills.
4.Self- motivated and driven to succeed.
5.Regulatory/ cGMP and compliance knowledge
6.ISPE(Q&C) guideline
Age: Below 35 Years
Qualification: Bachelor degree in Engineering (Mechanical/ Chemical)
Candidate should have experience in pharma industry
Forward CV s: Call at 9849006750

Competencies/Skill sets for this job

Startup Maintenance Biotechnology Electricals Process Equipment FAT SAT

Job Posted By

Sudha .

About Organisation

Ideal Consultants - Hyderabad