Company, Position & Person Profile. Cadila Healthcare Limited

Transcription

1 Company, Position & Person Profile Cadila Healthcare Limited

2 About Zydus Cadila Zydus Cadila is a fully integrated, global healthcare provider, with strengths all along the pharmaceutical value chain. With a core competence in the field of healthcare, Zydus Cadila provides total healthcare solutions ranging from formulations, active pharmaceutical ingredients and animal healthcare products to wellness products. Zydus is the only Indian pharma company to launch its own patented NCE Lipaglyn, the world s first drug to be approved for the treatment of diabetic dyslipidemia. The group s origin can be traced to 1952 when it was founded by Late Mr. Ramanbhai B. Patel, a first-generation entrepreneur and one of the stalwarts of the Indian Pharmaceutical Industry. In 1995, the group restructured its operations and Cadila Healthcare came into being under the aegis of the Zydus group. Zydus Cadila, today, is spearheaded by Mr. Pankaj R. Patel, the Chairman and Managing Director of the group. From a turnover of Rs. 250 crores in 1995, the group posted revenues of Rs crores in FY14. The group had posted a turnover of Rs crores in FY 11, making it a billion dollar company. It aims to be a leading global healthcare provider with a robust product pipeline and aspires to post revenues of Rs crores by and be a research-based pharmaceutical company by The Zydus group was one amongst the top five companies worldwide at the FT ArcelorMittal Boldness in Business Awards 2014 in the Developing Markets category and was declared as the Emerging Company of the Year by the Economic Times Awards for Corporate Excellence In January 2014, Mr. Pankaj Patel was conferred the India Innovator Award 2013 at the India Business Leaders Awards instituted by CNBC. Zydus Cadila with a mission to create healthier, happier communities globally is supported by a team of over people worldwide, comprising professionals, research scientists, medical advisors and associates. Poised for a higher growth and more success in the coming years, Zydus Cadila draws confidence from its proven track record, which both prescribes and projects a vibrant and soundly based future.

3 Zydus Group. State-of-the-art Manufacturing Plants

4 THE POSITION Organization Cadila Healthcare Limited Title Dy. General Manager Quality Assurance Location Ankleshwar Unit-II Job Summary To head Quality Assurance of API Ankleshwar Unit-II manufacturing location. Reports To Head CQA (API) Direct Reportees Manager QA, Section Head of of Quality Assurance Key Stakeholders Manufacturing, CQA,GDSO (Supply Chain Management), Quality Control, Regulatory Affairs, Marketing, Human Resources, Engineering, R&D, ADL Skill Set Quality Assurance, Change Control Management, Audit Management, Process Validation / Cleaning validation, Vendor Evaluation, cgmp Compliances, Documentation, IPQA, Site oversight, QA in QC

5 Dy. General Manager Quality Assurance (Head Unit-II) The position shall be responsible for Quality Assurance function of the site Pre-requisite: Qualification: M. Sc. (Organic Chemistry / Chemistry) Total Number of years of experience: years with atleast 5 years at managing Head level position in QA department of USFDA approved API manufacturing site. Must have a sound knowledge of cgmp Preferred Age Group: Between years Key Responsibilities: Ensure implementation of quality policy and systems at all levels Review and approval of process validation, cleaning validation, analytical method validation and equipment qualification protocols and reports Review & approval of specification and standard testing procedure of API, Intermediate, RM, In-process, API stability Review and approval of master batch record Review and approval of apex documents Responsible for executing self-inspection programme Release/Rejection of all API and finished intermediate to dispatch to various customers Review and approval of OOS investigation, change control and deviations Review, investigation, implementation of CAPA for market complaint and sales return License with govt. / Local agencies & ensure availability of license/ permission Responsible to handle the regulatory authority and customer audits and ensure the compliance with closure audit observation report

6 Responsible to conduct vendor audits for vendor approval To ensure that effective systems are in place for preventive maintenance & calibration of critical/non-critical equipment To ensure materials are appropriately tested and stability data is available to support retest/expiry data Coordinate and provide documents pertaining to drug master file (DMF) filings To adhere to quality policy, safety policy and Environmental policy Ensure the implementation of corporate Guidelines and initiatives. Responsible for technology transfer and related activities. Reports to head corporate Quality Assurance. Responsible for providing cgmp training To host regulatory and customer inspections and to prepare and authorize responses to audit observations. We share Zydus purpose and values. Our Purpose, Values and Principles are the foundation on which we develop leaders at Zydus. Our shared Purpose dedicated to life in addition to our Values meritocracy, integrity, humility and passion for winning unify us. We Hire the Best. We attract top talent because of Zydus 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 Zydus.

7 Zydus Neev: The Leadership Competency Framework

8 The Person Experience Hands-on expertise of handling Quality Assurance function at large scale API Pharma manufacturing facility in an environment of increasing regulatory complexity. Should have worked in Senior Management level and heading Quality Assurance function in regulated plants having approvals of US FDA, MHRA. etc. Should carry rich experience in Plant level quality assurance standards, audits and execution Should have sound knowledge in handling of various regulatory and customer audits Should able to plan and impart trainings on cgmp for all group of employees with effective implementation of practices at shop floor Hands-on experience in successfully handling and implementing cgmp (Current Good Manufacturing Practice) across different levels and departments of the site. Must have an established track record of successfully facing Regulatory audits. Working closely with Site & Regulatory functions to create a highly compliant environment. Strongly demonstrated success in managing large talent pool A strategic thinker and a result-driven doer, has the ability to understand business needs, provide strategic support, find the solutions and put good ideas into action. Create a culture of strategic excellence and encourage others to think long-term, developing strategic advantage and seeking opportunities for future development. An excellent people manager and leader; able to recruit, inspire, develop and retain a high calibre team across diverse departments. Able to work effectively within a global business culture whilst also adaptable to the local cultural environment.

9 Ability to energise his/her team with a clear vision of the business. Excellent communication and negotiation skills Should have an entrepreneurial and global mind-set. Strong analytical skills with knowledge of statistical tools Motivate people to give their best results, praising them when things go well and apprising them of improvements which can and should be made. Use researched factual information when solving problems and apply logics when handling conflict. Provide the best solutions in terms of quality and cost. Take decisions in a timely and appropriate manner whilst at the same time ensuring others follow similar principles. 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 Cadila uses benchmark HR practices and is known for employee centricity and well-being. We deploy scientific and objective methodologies like psychometric tools, inhouse Assessment Centers, one-on-one discussions with our leaders panel while taking people aboard. Good Luck!!!