Company description
greetings
aarna hr solutions is bangalore based human resource recruitment company providing services to various it, ites and non- it companies across india. Aarna solutions strive towards hiring the best and the brightest talent in the industry. We hire individuals with a strong sense of pride in their performance, team spirit, and a desire to excel.
we have openings for "commissioning & qualification lead engineer" position with a reputed company located in bangalore and have to work for client located in europe.
job description
about position:
position: commissioning & qualification lead engineer
experience: 10+ years
qualification: any pg/ug
location: candidate will work for overseas location- europe. Will work for our client.
job description:
* the c&q lead will be responsible for on-site c&q activities following ispe/astm methodologies utilizing gdp, gep & cgmp principles.
* they will lead a team of validation/verification, commissioning engineers/ subject matter experts to perform the commissioning/qualification of equipment, utility systems, facilities and automation systems for a number of blue chip pharmaceutical clients.
* we aim to expand our operations with the assistances of the c&q lead. We are searching for a driven individual who has +10 years industrial experience in a c&q lead/ senior validation/engineering position with previous work experience in a gmp environment & large scale capital project or start-up projects in the life science industry.
other skills and abilities:
* detailed understanding of regulations/guide lines & industry practices for
c&q/verification methodologies (ispe/astm).
* excellent written and verbal communication skills.
* self-motivated and willing to take ownership and drive projects to completion.
* excellent organization skills.
* ability to handle multiple tasks accurately and prioritize effectively.
* ability to work on own initiative or as part of a team.
* demonstrates flexibility, attention to detail, an aptitude for analysis and an ability to apply standard problem solving tools for resolution.
* interaction and teaming with cross functional teams (internal/ external) and ability to lead in areas of conflict resolution.
main duties:
c&q project lead main duties outlined below:
* liaise with client as company representative.
* planning, developing, execution, reporting of c&q deliverables.
* liaison with the design lead (architect engineer), project manager, other stakeholders to enable effective leveraging (where applicable) and timely right first time execution and compliance of commissioning & qualification deliverables.
* provide leadership in assigning work and providing resolution to a wide range of problems.
* management of contractors, scheduling, resources, budget.
* trending of data, issuance of reports in a timely & accurate manner to support project metrics.
* review and approval of protocols, reports and associated deviations as applicable.
* maintain master plans & inventory of systems.
* generation, review and approval of c&q strategies as applicable.
* interfacing with global/local client representatives to ensure compliance.
* represents the validation methodology and outputs at compliance quality / regulatory inspections.
* conducts training as required.
* generation of sops/ other documentation as applicable.
* maintain change control system for projects.
key consideration:
previous experience leading projects in pharmaceutical, biopharmaceutical and or medical device industries, covering (clean and black) utilities, facility clean rooms, process equipment & automation systems (c&q baseline guides / astm 2500e :sd&v/ gamp 5) is essential to this role.
qualifications
any graduates/pg
additional information
if interested please send your updated profile with below mentioned details.
current ctc:
expected ctc:
notice period:
reason for job change:
with regards,
shruthi b - hr recruiter
aarna hr solutions pvt ltd
mob no: ;