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 : GENERAL PRODUCT QUALITY MANAGER
Job Responsibilities:
- Compliance with the GMP, EHS and SOX requirements and guidelines, as applicable.
- Serves as the single point of Global Quality contact for an assigned group of marketed products. Responsible for ensuring end-to-end Quality for assigned products across DS site(s), DP site(s), packager(s) and QC testing and release. The Quality Owner (QO) knows the product history and understands the processes across the various manufacturing sites. The QO establishes and maintains site Quality contacts and drives communication with all Q&C stakeholders. Assures Quality milestones and Quality deliverables are achieved, and approves content of spec changes to ensure spec changes are aligned end-to-end. Assures multisite/global/high level product CAPAs and change controls are approved and closed appropriately.
- Represents Global Quality on the Value Stream Teams (VST). Maintains the flow of communications between Global Quality and VST teams. Brings Quality issues to the VST and assists with prioritization of projects and with key product decisions. Supports the business continuity process including VST strategy and BCP projects. Reviews Proactive Product Quality Scans with the VST and assures appropriate mitigating actions are defined there. Prepare quality sections of Product Strategy and End-to-end Value Stream Mapping. Participate in the F2F VST meetings on PSR and VSM finalization and project prioritization. Align and interface the JSC Product Strategy with other existing strategies: J&J corporate strategies, commercial strategies, R&D strategies, regulatory strategies, etc.
- Defines and oversees the necessary QA resources for global and local Q of his or her assigned products.
- Leads a comprehensive Quality Sub team that assures Quality throughout, DS, DP, Fill Finish & device: Assures product quality over the life cycle, understand the performance, and risk profile, throughout shelf-life.
- *Assures patients get the right quality products.
- Supports the sites, represents the sites on VS Team.
- Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
Ensures standard Global Quality processes (risk assessments, technology transfers) are used across sites and facilitates communication throughout Global Quality
- Manages preparation of the PPQS in advance of Review Board and Executive
- Management Review.
- Supports preparation of the criticality analysis per schedule.
- Ensures complaints are well managed, issues are understood, and trends in Global Medical Safety, GMS are understood and addressed as necessary. Participate in product safety management teams to present Product Quality Complaints trends and topics.
- Coordinates and/or owner of complaints trend signal investigations.
- Partners with Quality Integrator to complete Transfer of Ownership activities.
- API, RM, FP specifications change approvals.
Presents project updates to QM for Global Quality alignment
* Escalate issues when appropriate. Works with the cross functional/site teams to coordinate and hold Escalation meetings, minutes archival, follow up on actions.Participates and actively engages on IMTs. Supports field/recalls as needed.
* Review/approval/support regulatory filings and answering questions from the agency during filing review.
Support agency audits for the product assigned.
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Decision making and Problem Solving:
Drives/coordinates decisions and makes decisions on behalf of Global Quality including sites.
Gives input to the development of new strategies and implements and deploys strategies. Aids which will influence the life cycle management strategy and the total quality cost during commercial production.
Provides Quality structure, direction and decision making to the teams (Quality and VST) in situations of medium risk, uncertainty and ambiguity.
Innovation/Creativity:
Expected to bring creative solutions to define a compliant quality strategy with flexibility for business needs, thus providing the best total value to the company.
Candidate Profile :
Educational Qualification – Bachelor in Chemistry / Pharma, Master is preferred.
Minimum 13 years of experience in Pharma Product development/ Manufacturing / Quality.
Additional Information:
Experience: 13 years
Qualification: B.Sc, B. Pharm
Location: Greater Mumbai, India
Industry Type: Pharma
Functional Area: Quality (Generalist)
Last date : 25th March, 2017
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