Title :- Junior Process Validation(Onsite)

Visa :- OPT-EAD works only
Location : Onsite in Trumbull CT - 5 days a week

Interview:Phone+Skype

Job Description:

Must have strong working knowledge in:

21CFR820, ISO13485:2016, ISO14971
Process validation (IQ/OQ/PQ/TMV/MSA)
Ideally both in transferring/scaling up existing processes as well as developing new processes
NCMR, CAPA, Change control and GDP experience
At least 3 years of experience in the medical device industry
Experience in integrations/acquisitions with respect to ensuring quality requirements are preserved pre-post integration.
Presentation of results in a logical and clear manner
Ability to analyze information and come to conclusions based on presented data
Ability to communicate effectively both orally and in writing
Strong organizational and interpersonal skills
Ability to learn and utilize computer in standard business applications including electronic document control, word processing, spreadsheets and databases.
Background in statistics with respect to process control (reliability, capability, SPC, etc.)
BS Degree in Life Science, Engineering or equivalent program is preferred
Qualifications

Background in statistics with respect to process control (reliability, capability, SPC, etc.)
BS degree in Life Science, Engineering or equivalent program is preferred
General Comments

12 months duration to start
Someone with Strong Process Validation knowledge IQ OQ PQ TMV/MSA (Validation Master PLAN VMP-Manufacturing process experience)
NCMR Capa experience crucial here
MSA (GR&R) protocol and report writing, execution
PFMEA execution
Statistics general knowledge very Important here with respect to process control (sampling for validations, Sampling for in process inspections)
Med Device experience
Must have bachelors degree

Himanshu Goswami

IT Technical Recruiter

Stellent IT Phone: 3217856032

Email: Himanshu.goswami
Gtalk: Himanshu.goswamiom