Zydus Hospira Oncology Pvt. Ltd.

Transcription

1 Company, Position & Person Profile Zydus Hospira Oncology Pvt. Ltd. 6/7/15

2 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.

3 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

4 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 years

5 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

6 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

7 The Person Experience 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) 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!!!