CSV_Engineer

We are #Hiring: #CSV_Engineer

Job Title : #CSV_Engineer

Location : Navi Mumbai - (Hybrid)

Total Yrs. of Experience : 3 to 5 Years

️ Duration: Contract to Hire (C2H)

Notice Period: Immediate Joiners to 30 Days

Job Description*:

· Candidate must have 2 to 4 years of industrial experience in a reputed Pharma /Life science domain

· Candidate must have an equivalent combination of working experience in QA activities along with IT and CSV domains.

· In-depth knowledge of various following regulatory guidance

· 21 CFR Part 11, Electronic Records; Electronic Signatures

· Annex 11: Computerized Systems, European Commission, Health and

Consumers Directorate-General

· GAMP 5: Good Automated Manufacturing Practices

· WHO, MHRA & USFDA guidance

· ICH Q7, Q8, Q9 & Q10

· Data integrity guidance

· Work experience in both the IT sector and the pharma sector will be desirable.

· Hands-on experience and knowledge of various software (including manufacturing, laboratory, enterprise, SAP, warehouse, etc.)

· Experience in validation on automation/digitization projects

· Should be good in communication skills (verbal and written), good documentation and technical writing skills, Good logical thinking, problem-solving, and decision-making skills

· Candidate should have good exposure to handling CSV for the enterprise application like SAP, Track wise

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Thanks & Regards

P. Sona

Talent Acquisition

Burgeon IT Services Pvt.ltd.

Email : ,

Website:www.burgeonits.com

USA AUSTRALIA INDIA

Shirisha. Ch Sona P Thota Harika Ramya Sarige k Nitusha Kalyani R Sudha Yadav Veeraboina Syed Nazima Vara lakshmi kota Golagani Saikumar Shiva Kumar Rajkiran G Srikanth Vicky Khaja Mansoor Ahmed Kiran Gomasa Nagarjuna Duggineni Masthanvali SHAIK Nanda Kishore Kumar Lakkakula Laxmi Narayana (Raja) Arraganti palley Mahathi Navya Tumuluri BURGEON IT SERVICES