Company, Position & Person Profile
Zydus Hospira Oncology Pvt. Ltd.
6/7/15
About Zydus Hospira Oncology Pvt. Ltd.
Zydus Hospira Oncology Private Limited (ZHOPL) is a joint venture company in Ahmedabad,
India jointly owned by Cadila Health Care Limited, a company incorporated under the Indian
Companies Act, 1956 and Hospira, Inc., a company incorporated under the laws of the
State of Delaware, USA. ZHOPL manufactures oncology drug products that is
marketed, sold and used throughout the world. ZHOPL was set up in 2005 as a JV
between Cadila Health Care (Zydus Cadila) and Mayne Pharma Ltd, Australia (Mayne
Pharma was acquired by Hospira Inc.,USA in February 2007 hence this company is
since known as Zydus Hospira).
Cadila Healthcare has the expertise in handling a wide variety of finished dosage forms
of pharmaceutical drug products and has the ability to establish and operate
pharmaceutical projects of world-class standards and secure regulatory approvals from
global regulatory bodies, such as the United States Food and Drug Administration,
MHRA.
Hospira, Inc. is a global speciality pharmaceutical and medication delivery company that
develops, manufactures and markets healthcare products that help improve the safety,
efficacy and costs of patient care.Hospira’s portfolio of products and services includes
speciality
injectable
pharmaceuticals,
medication
delivery
systems,
injectable
pharmaceutical custom manufacturing services and other products, including critical
care devices.
Vision
To be Hospira’s Preferred Manufacturer for oncology products and
become a centre of excellence.
To be no 1 Cytotoxic Manufacturer in India for global markets and increase penetration
from 24 to 59 markets across the globe by 2015
Zydus Hospira Oncology Pvt. Ltd. …. State-of-the-art
Manufacturing Plants
THE POSITION
Organization
Zydys Hospira Oncology Pvt. Ltd.
Title
Officer – Quality Assurance (Validation)
Location
Pharmez – SEZ ,Ahmedabad.
Job Summary
To ensure compliance in QA-Validation related activities in
ZHOPL
Reports To
Senior Manager – Quality Assurance (Validation)
Direct Reports
None
Key Stakeholders
All departments of ZHOPL
Key Skills
Quality Assurance/QA, Quality Assurance
Officer – Quality Assurance (Validation)
Senior Manager –Quality Assurance (Validation) shall be responsible for managing
Validation activities and compliances related at ZHOPL.
Pre-requisite:

Essential Qualification: B.Pharm

Total Number of years of experience: 0-2 years with clarity in concepts of
B.Pharm

Must have a sound knowledge of basic concepts of B.Pharm and cGMP
requirements form the Quality Assurance and Regulatory perspective.

Preferred Age Group: Between 20– 26 years
Key Responsibilities:
1.To validate various equipment in the plant and processes like mixing, filling, CIP, SIP and
sterilization under the guidance of Manager Validation.
2.To get involved in various processes related to validation of Production processes
(equipment,
process and cleaning validation) and quality control equipment under the guidance of
Manager Validation.
3.To help in Preparing Installation Qualification / Operational Qualification / Performance
Qualification Protocols of new equipment and Re qualification protocols for existing
equipment of the site.
4. To do the technical documentation of equipment / process validation in consultation with
various department.
5. To execute validation protocol of equipment, process, system and facility for Production,
Quality control and Engineering.
6 To initiate exception, change control, Deviation and CAPA as and when required and
responsible for closure of the same.
7. To perform the sampling during mixing, filling, CIP and SIP validation as per predefined
schedule and location.
8. To Ensure the Implementation of cGMP in all aspects of manufacturing and other
processes of Plant.
Zydus Hospira Oncology Pvt. Ltd.’s Mission and values.
Mission
To be customer centric organization with the best Quality , Cost and Service
Values
Integrity and Transparency
Quality Culture
Management mindset: Quality is not expensive it is priceless
Respect and understanding
We Hire the Best.
We attract top talent because of ZHOPL’s reputation as a great company for leaders,
and we identify the best applicants by using a proven recruiting process that measures
intelligence, assesses character and leadership, and predicts success at ZHOPL.
Zydus Neev: The Leadership Competency Framework
The Person

Fresher should be well versed with the basic
concepts of pharmacy and experienced should have
hands-on expertise of handling Quality Assurance
(Validation) related activities of Manufacturing unit
(Preferably Pharma unit) in an environment of
increasing regulatory complexity.

Should have worked in Quality Assurance –Validation
Section/Activities in regulated plants having approvals
of US FDA, MHRA. etc.

Hands-on experience in successfully implementing
cGMP (Current Good Manufacturing Practice)
Experience
Interview Process
Zydus Hospira Oncology Pvt. Ltd. uses benchmark HR practices and is known for
employee centricity and well-being. We deploy scientific and objective methodologies
like psychometric tools, in-house Assessment Centres, one-on-one discussions with our
leaders’ panel while taking people aboard.
Good Luck!!!