CSV- Senior Consultant
Found in: Whatjobs IN C2 - 2 weeks ago
Due to a constant growth PQE is looking for a CSV-Senior Consultant based in Bangalore, India who will be responsible for conducting CSV and QA related activities according to the required CGMP regulations.
Responsibilities include, but are not limited, to the followings:
1) Hands on experience in change management
2) Well versed on the SDLC process for GAMP 4 and 5 systems (ERP systems)
3) Well versed with the CSV documentation process and preparation (Validation Plan, Design doc etc.)
4) Hands on experience on procedural documents (SOP and WIs)
5) In depth knowledge of the regulatory requirements in terms of Data integrity.
Requirements:
· At least 6-7 years of experience in Pharma Industry with a graduate degree in life sciences. Post-graduation degree in life science is an advantage.
· Familiar with software regulation requirements such as: CFR 21 part11, Annex11, GAMP5,
· Demonstration organizational skills and ability and independency
· English language fluency in speaking and writing
· Experience in global projects within the Life Science industry.
· Open for travel as per the business requirement
· Highly Self-motivated, self-directed.
· Excellent use of office package (word, excel, powerpoint, outlook, visio).
Location: Bangalore, India (Should be open for travel in India as well as abroad)
Our collaborators are engaged, developed, challenged and well-rewarded for performance.
We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.
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