Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products. The organization is comprised of more than 250 operating companies with over 128,000 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.
Post : Plant Quality Manager
Job description
Representative for the plant. Lead the Quality System execution at the plant, whose primary function is:
Achieve product quality systems goals/site
Assure execution of the quality system at the plant, and utilize process excellence tools/ methodology for continuous improvement and predictability
Maintain plant in compliance with Quality System Regulations
Establish and maintain JJMC Ethicon Baddi site Quality System to ensure comply with ISO13485, WHO GMP for MDD and J&J internal standards and Franchise requirements.
Assure execution of quality system at Ethicon Baddi site, and utilize process excellence tools/methodology for continuous improvement and predictability.
Serve as Management Representative for the plant.
- Effective implement Quality System strategy defined by WW Quality System & Compliance and Drugs and cosmetics act.
- Ensure that the facility remains continually certified to ISO.
- Coordinate ISO compliance efforts within the facility.
- Have a thorough familiarity with the requirements of the ISO Standard
- Have a thorough knowledge of Ethicon’s Quality System.
- Ensure that the Quality System is regularly audited/reviewed and that changes needed are implemented in a timely fashion.
- Serve as a resource by recommending appropriate compliance efforts and proposing improvements to the Quality System.
- Ensure all facility associates are educated in the regulatory requirements.
- Maintain plant in compliance with Quality System Regulations
- Ensure plant have appropriate resources with the right competencies to execute the Quality System.
- Maintain systems that assure only acceptable raw materials are used in processes and that only acceptable materials are shipped. Provide timely information to Management on the status of conformance to requirements.
- Maintain an effective
- Quality Information System (Doc Management, NCR, etc). Review and act as approval authority or delegated authority, retaining responsibility for all specifications, protocols, validations, fact books, and non-conformances.
- Enforces, promotes and observes all safety, industrial hygiene rules and regulations established by the Company.
- Takes appropriate actions to create and maintain a working environment aligned with OUR CREDO.
- Support Quality Improvement Processes, Affirmative Action objectives and all activities to achieve World Class Manufacturing plant.
- Participate or support major plant projects, such as transfer of new product or process.
- Establish, and operate within, an effective budget and manpower plan for the QA organization.
- Recruit, select and develop adequate human resources. Support plant objectives in Safety, Health and of maintaining environmentally neutral operations.
- Scope of operation encompasses approximately 20 - 30 employees on multi shift chedules.
- Direct subordinates are Quality Operations Leader.
- Reviews and participates in personnel development programs necessary to provide employee movement through prescribed promotional patterns.
- Evaluates and recommends staffing requirements to insure maximum utilization of personnel to fulfill department objectives.
- Annual appraisal of team members
- Appraise direct reports performance & recommends salary increases and promotions for direct subordinates.
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AUTHORITIES (if applicable)
- Authorized signatory for regulatory submissions
- Approval of NCR, CAPA, DHF, Change control, SOP, Spec, Protocol and other QMS documents.
- Approval of Audit Schedules, Audit Reports
- Approval of validation documents, design change, ECNs, DCN
- Approval of artwork
- Approval of supplier bills as per current authority matrix
- Approval/ Rejection of material.
- Signing of Material Outward (Returnable & Non-Returnable) Gate Pass
Additional Information:
Experience : 12 to 15 years in Quality Assurance and/ Medical Device
Qualification : Master / Bachelor degree.
Location : Baddi
Industry Type : Pharma / Biotech / Clinical Research
Functional Area : QA Manager
Last date : 20th Octocber, 2016
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