Job in Quality Assurance as Manager at Johnson & Johnson

Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products.In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices which are independently managed and report into their respective Global business segments.

Post : Manager QA

Role Overview
Responsible to ensure that quality system & quality operations requirements of JJMI Business Quality are effectively established and effectively maintained in accordance with the WW Quality Policy & compliance, BQ requirements and local requirements and reporting the performance of the quality system to management. Extend adequate support in the quality operations activities as required by the organization. Responsible for various internal and external QMS audits.

Job Description
DUTIES & RESPONSIBILITIES

Effectively implements Quality System strategy defined by WW Quality System, BQ standard & Compliance and Drugs and Cosmetics Act
Possesses a thorough familiarity with the requirements applicable under Drugs & Cosmetics Act & ISO 13485/ISO 9001 & ensure established system remains in compliance
Ensures that the Quality System is regularly audited / reviewed and that changes needed are implemented in a timely manner.
Ensures all stakeholders are trained on the quality & regulatory requirements.
Ensures periodic review/inputs of Quality Agreements and Change controls (as applicable)
Maintains an effective Quality Information System (Doc Management, Compliance Wire, ETS Trackwise, etc.)
Actively participates and contributes in periodic Management Review meetings
Review and act as approval authority or delegated authority, retaining responsibility for all specifications, protocols, validations, fact books, and non-conformances & CAPA
Takes appropriate actions to create and maintain a working environment aligned with J&J’s CREDO.
Oversees quality assurance auditing of service providers and systems (Supplier audit and Internal Audit)
Support Quality Operation (warehousing operations, 3PL management, audits, distributor management practices etc.) and collaborate with CLS quality.
Support Quality Improvement Processes, Affirmative Action objectives and all activities to achieve Various Quality Objectives.
Participates / Owns the execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner.
Escalate all significant quality issues as and when made aware of.

Candidate Profile

Master’s degree in Science / Bio Medical Engineering
8 to 10 years of experience in Quality Assurance , Quality Control in Medical Device / Pharma Industry
Around five (5) years in supervisory role
Regulatory compliance Knowledge and skills…preferred
Advanced Quality System Knowledge
Interpretation and application of Drugs & Cosmetics Act, QSR and ISO Standards
Excellent communication and interpersonal relation skills
Statistical and analytical problem solving
Advanced computer and use of software applications

Additional Information:
Experience:- 8-10 years
Qualification: MSc
Location: Mumbai
Department: Pharma
Job Function: Quality Assurance
Requisition ID: 1700170425W