Career for M.Pharm, M.Sc as Manager in CLS Quality & Compliance at Johnson & Johnson

Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Johnson & Johnson strives to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life. The organization is comprised of more than 250 operating companies with over 127,000 employees located in some 60 countries. With Global sales of USD 71.3 billion in 2013, Johnson & Johnson is recognized as one of the most admired and respected companies in the world. Johnson & Johnson companies are equal opportunity employers.

Post : Manger CLS Quality & Compliance

Job Description
The position is designed to ensure

Oversight and execution of QMS and compliance at all CLS medical DC’s in India under CLS Q&C scope that receive , store , pick , pack and Deliver finished goods to customers, wholesalers, distributors and retailers.
Serve as single point contact to India CLS lead in medical franchise distribution quality related matters and liaise with multiple quality organizations to drive timely resolution of quality related issues.
Define and implement departmental strategies and services as the business expert on quality systems, distribution, and quality management. In collaboration with Enterprise CLS Quality and other sectors , develop common distribution standards and QMS and implement accordingly.
Plan , co-ordinate and direct quality assurance programs designed to ensure effective and consistent process with established standards by performing following duties personally or through subordinates
Ensure compliance to applicable Johnson & Johnson Quality policy standards and Technical standards

Distribution and Inventory Management Process
* Accountable for overseeing the controls and quality standards for all distribution and inventory management activities.
* Accountable for robust product disposition procedures and the quality oversight of all product quality holds and field actions impacting the distribution centers.
* Responsible for evaluating the company’s quality and distribution process capabilities against company and industry standards and regulatory expectations.
* Accountable for adherence to temperature control and monitoring requirements within facility and during transportation.
* Accountable for validation of cold chain facilities and validation of cold chain and controlled ambient pack out and transportation lanes.
* Accountable for accurate and timely communication of temperature control excursions occurring within DC to appropriate partner .
* Accountable for the investigation of temperature control excursions and subsequent remediation activities.
* Accountable for implementation of processes for labeling activities at FTWZ and bonded warehouses.

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Quality Management Systems.
* Responsible for ensuring the appropriate handling of distribution related customer complaints including track and trend and mitigation of quality related issues for medical DC’s.
* Responsible for overseeing the controls and quality standards of Quality system validation including CAPA and NC.
* Accountable for management of Quality systems, including CAPA process and systems document management , change control , training management , preventive maintenance systems, Quality agreements.

Qualifications

knowledge of the quality Management system as per ISO9001 and ISO13485
Knowledge of the India regulatory requirements related to distribution of products
Good knowledge of the distribution practices
Knowledge of the process validation and qualifications
Minimum 10 Years of experience
PG in Science or Pharma

Additional Information:
Experience: 10 years
Location: Greater Mumbai, India
Job ID: 1700164433W
End Date: 10th June, 2017