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Commercial Quality Manager, India

3 months ago


Hyderabad, Telangana, India West Pharmaceutical Services Full time

At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

JOB SUMMARY

In this role, the Manager Quality will provide support to the India Commercial Team on quality related matters

Essential Duties and Responsibilities

Take care of all Quality related customer requirements and support the key account management, including but not limited to :

Review quality feedback from customers and formulate action plans to improve customer relations Lead meetings between customers and manufacturing sites on critical quality complaints by working together with global manufacturing sites on appropriate and efficient complaint management, e.g. follow up on root cause determination, corrective and preventive actions identification and implementation Be the contact person between customers and manufacturing sites on audits, serious findings, root causes and CAPAs where needed Manage complex quality related queries from customers including but not limited to Change Notifications, Quality Complaint Report, Quality Agreement, Audit Report, COA/COC etc Work closely with internal stakeholders – i.e. Operations, Technical Customer Service, Sales, Product Management – to assure that customer Quality issues are resolved and that the needs of the customer are being met. Chair Quality Reviews for major key customers where relevant Be the quality representative to manage regular Quality Reviews with key customers of the region This role will monitor/ trend customer Quality information and use this information to highlight where improvements in performance are needed. Enhance customer relationships by improving quality performance across key indicators. Other duties as required.

BASIC QUALIFICATIONS

Education

Education Level

Education Details

Required/
Preferred

Bachelor's Degree

in pharmaceuticals, biochemicals, chemicals, or other related majors

Required

Work Experience

Experience

Experience Details

Required/
Preferred

Minimum 8 years

experience in a quality role

Required

Preferred Knowledge, Skills and Abilities

Working knowledge of Quality Management, Production processes in the field of primary packaging for pharmaceutical application (ISO 15378, ISO13485) Familiar with ISO9001, GMP, ISO15378,ISO14001 and other quality system Certified ISO9001 and ISO15378 internal auditor Knowledge of QA techniques and management as well as applied statistics including SPC Good communication and interpersonal skills, strong team spirt Familiar with MS Office and ERP/SAP system, and Good command of English both oral and written Aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description Support and contribute in Lean Sigma programs and activities towards delivery of the set target Able to comply with the company's safety policy at all times Able to comply with the company's quality policy at all times.

Travel Requirements

Estimated Amount

10%: Will involve travel for critical quality issues at customers

Physical Requirements

Job Demand Classification

Details

Sedentary

exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.

Additional Requirements


Good command of English


Represent West in customer facing meetings so is able to make agreements/ commitments that are within his area of responsibilities. Any commitment that implies sites activities or product quality beyond the normal offering would need to be agreed upfront with relevant parties

The job description reflects the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all the work requirements that may be inherent in the job. West Pharmaceutical Services is an Equal Opportunity Employer.