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
Deputy Manager-Quality Compliance
Location
Pharmez – SEZ ,Ahmedabad.
Job Summary
To ensure analytical compliance
Reports To
Deputy General Manager-Quality Assurance
Direct Reports
Officers, Executives-Quality assurance
Key Stakeholder
All departments of ZHOPL
Key Skills
Compliance Cell
Deputy Manager-Quality Compliance
Deputy Manager-Quality compliance shall be responsible for ensuring and timely
completion of analytical compliance at ZHOPL.
Pre-requisite:

Essential Qualification: M.Sc/ B. Pharm

Total Number of years of experience: 6-8 years and above in analytical
compliance in Quality assurance or Quality Control-Chemistry department at
manufacturing sites supplying to US , Europe markets.

Must have a sound knowledge of cGMP requirements from Quality compliance
perspective.

Preferred Age Group: Between 25 – 32 years
Key Responsibilities:

.
To prepare and review SOPs for Q.A department.

To compile the data and to prepare Annual Product Quality Review.

Review and approval (where required) of the Standard Operating Procedures of
the plant.

To review and approve the change control, deviation, Corrective and Preventive
action report, Effectiveness Plan, Hold Notice, Critical Work order, Breakdown
Intimation slip, out of specification, update the log and maintain the reports for the
same.

To review and control the quality documents like Master Production and Control
Record, Master packing Records, Specifications, test procedures etc. of the
plant.

To review all Change control, Deviation, CAPA, EP etc. pertaining to Quality
Control lab.

To perform Internal Audit, mainly of Quality control department.

To perform GAP assessment of all practices of Quality Department.

To maintain the log for technology transfer documents, completed documents &
records.

To prepare the schedule and vendor list for vendor qualification.

To prepare schedule for internal audit and to coordinate, conduct and close the
observations after appropriate corrective actions.

Documenting the change controls and ensuring the process during break down
and other critical condition and documenting the same.

To select the batches and collect the samples for stability study for the respective
product manufactured.

Handling the product complaint and immediately responding to the Head Quality/
QA Manager on receipt of the complaint.

To ensure the stability management as per SOP and regulatory requirements.

To receive, distribute and maintenance at site and printer’s end art works of
printed packaging materials as per the SOP and regulatory requirements.

To review the test reports of materials and products, calibration report, by
reviewing chromatograms, audit trails, logbooks, data generated through
instruments, calculations, trend reports etc.

To complete the assessment of New Product Introduction as per SOP

To update the compliance to compendia as and when new bulletin from external
partner/ compendia received

To ensure availability of updated Approved Vendor List. Review and monitoring of
suppliers of materials.
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
Experience

Hands-on expertise of handling analytical compliance
and Regulatory requirements independently, and
handling complexities arising in the process.

Should have worked Quality Control-Analytical
Compliance in regulated plants having approvals of
US FDA, MHRA. etc.

Hands-on experience in successfully handling and
implementing cGMP (Current Good Manufacturing
Practice).

Working closely with Quality & Regulatory functions to
create a highly compliant environment.

Must have sound knowledge handling regulatory and
analytical compliance.

Strongly
demonstrated
success
in
capacity
enhancement initiatives in solving issues in
Compliance related activities.
 Bring a sense of urgency to situations, demonstrate an
active approach, be willing to get involved in order to
increase the pace and achieve goals and objectives.
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!!!