Overview

Role:

To act as Business process improvement manager, meet functional heads to understand relevant processes, and collaborate to design/implement their IT needs with the help of in-house IT team and consultants

Responsibilities:
To prepare SOPs, policies, reviews in-line with current regulatory environment and maintain them periodically
To ensure and conduct training activities (both internal & external) to upgrade staffs technical competency on the new and existing software solutions, IT SOPs etc.
To prioritise multi-tasks effectively; taking into account factors such as project scope, deadlines, and urgency of need,and to ensure desired business results
To act as a liaison with the vendor for finalising project requirements, defining project timelines and ensuring/establishing SLA’s to meet all internal expectations
To align organisational reporting needs& goals with help of IT anddata analysis skills and systems
To assist in management audits (internal & external) including audits ofUS-FDA,EU,MHRA,ANVISA,MCA, TGA, WHO,etc.
To coordinate with site QA team,manage preparation of validation activities, and review of documents like validation plan, specifications (user requirements, functional, design, etc.),risk assessment, test plan &script, traceability matrix, validation summary report, user training manual & others for software and equipment
To ensure compliance for computer system validation requirements, policies &procedures in line with the applicable regulatory requirements (GAMP5, 21CFR Part 11, EU Annex 11)
To provide written and verbal communication including status reports, progress reports, and documentation to management & business partners.
Salary:INR 5,00,000 – 15,00,000 P.A

Industry: Pharma / Biotech / Clinical Research

Functional Area: Analytics & Business Intelligence

Role Category:Analytics & BI

Role:Business Analyst
Keyskills
ITIL SOX Compliance Risk Management IT Service Delivery IT Governance Test Planning Computer System Validation Risk Assessment Validation Testing o Project implementation gamp5 project manager information technology sop
Desired Candidate Profile
Education-

UG: B.Pharma – Pharmacy, B.Tech/B.E. – Computers, B.Sc – Computers

PG:MCA – Computers, M.Tech – Any Specialization, Computers, M.Pharma – Pharmacy

Doctorate:Any Doctorate – Any Specialization, Doctorate Not Required
Desired Skills &Experience:
4-10 years of experience as a part of core team, preferably working with a pharmaceutical company or an IT company handling outsourced activities of a pharma corporation

Experience in :
Project implementation: IT + CGMP and Regulatory Affairs
Periodic compliance evaluation of IT systems, to maintain the validated state: user access reviews and system configuration reviews
Computer System Validation (FDA – 21 CFR Part 11, EMEA, etc.), QMS i.e. change controls, deviations, investigations, risk assessment/FMEA, etc.
SDLC and STLC: specialised in developing validation test strategies & plans
IT governance & risk management in view of GxP, SoX compliance,
IT projects delivery aligned with GAMP5 methodology to ensure compliance to pharmaceutical regulatory requirements
IT service delivery for various GxP critical applications
Exposure of
International laboratory establishment inregulate environment USA/EU
Handling CCN, OOT, OOS, LER, deviation etc.
21 CFR Part 11 compliance and EU annexure XI requirements for Waters, Dionex, Shimadzu and Agilent softwares (electronic signature and auto calculation)

Educational Qualification:
Preferred Certifications:  Short term courses regarding ITIL/ITSM/compliances & regulations, etc.

Personal Attributes:
Good communication skills, pleasant personality, team management capabilities, managing multiple responsibilities and partnering with different stakeholders.

Company Profile:
Claris Lifesciences Limited

 

Claris Lifesciences is an IPR driven international pharmaceutical company, in the business of manufacturing and marketing of high end injectables with focus on New Drug Delivery Systems for treatment of critical illnesses and diseases.

With emphasis on Quality, Technology & Innovation, Claris offers a range of niche technology Aqueous & Lipid emulsion injectable products across delivery systems such as bottles, vials, ampoules, non-PVC/PVC bags . The company’s strength lies in its know-how and expertise in manufacturing and marketing injectable products.

Driven by a team of scientists, pharmaceutical experts and management professionals, Claris is powered by a combination of Vision, R&D capabilities, Technological know-how, International standards and Manufacturing expertise , an expanded Proprietary Marketing Network and Ambition to be one of the world’s leading and most admired pharmaceutical companies in the global generics space.

The company’s range of products and delivery systems extends across Enteral and Parenteral Nutrition, Anaesthesia, Blood Products and Plasma Volume Expanders, Anti-infectives, Dialysis and Transplant, Oncology & Infusion Therapy.

Claris enjoys Market Leadership in India. Globally, the company operates in more than 76 countries, through its subsidiaries, offices and marketing/distribution network, and a diverse customer profile covering institutions, large corporate hospitals and international aid agencies.

Recruiter Name:Mr. Tejas Thakker

Contact Company:Claris Lifesciences Limited

Address:Corporate Towers, Near Parimal Railway CrossingEllisbridgeAHMEDABAD,Gujarat,India 380006

Website:http://www.clarislifesciences.com

Telephone:91-79-26563331

 

Tagged as: compliance risk management, it governance test, it service delivery, itil sox, planning computer system