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Responsibilities:
Ensure continuous improvement of site quality system as per the requirement of Schedule M, MHRA, SAHPRA, ISO 9001 and other regulatory authorities.
Ensure compliance and improvement of site quality system for new markets viz regulatory agencies TGA, MoH Ireland, Medsafe (New Zealand)
Ensure PIC/s compliance for Disprin and for DAL export.
Ensure, monitor, and improve Quality performance of manufacturing site including new DAL facility, DAL 5 L line and DDL facility.
Promote Quality attitude, awareness and mind set of the site by all proper means including training.
Implement, audit, and develop quality system, in line with Global Quality policy/manual and the procedure relevant to area.
Lead and manage the local quality team of Quality Assurance and Quality Control.
Systematically reduce the cost of quality within the business while maintaining agreed quality standards.
Ensure conformances of products with agreed specifications including additional volumes of DAL for North Africa market and DDL for India market.
Ensure necessary process controls are in place, including hand-over from R&D for residual 10 Disprin SKUs from Reckitt Hull.
Ensure consumer safety and company compliance with regulation.
Manage customer complaints to ensure timely investigated and implement appropriate corrective and preventive actions including new markets
Managing material suppliers and sub-contractors for site and ensuring compliance of standards of Reckitt’s, ICH Q9, PS 9000 and other quality standards. Manage the same for additional suppliers, BCP suppliers and global suppliers assigned to Mysore.
To approve the site policy and procedure’s like VMP, SMF, PVMP, Protocols, specifications test methods, batch documents & other site documents.
To act as a Validation Manager as per site VMP to ensure that the appropriate validations comply with relevant GMP requirement including new DAL facility, DDL facility, Cauvery-II facility.
To approve the validation programme and provide analytical services for process validation.
Ensure and built back up for timely release of starting Material, Packaging material and finished product including additional materials of DDL and Cauvery-II products.
Manage all changes in the quality management system those concerned to quality of product to ensure that they are in proper control and implemented in an appropriate way e.g. usage of KIDB water and qualification of new CN Water System.
To ensure the management review and annual product review program are maintained according to concerned GMP and QMS requirement.
To maintain Site Master File and compliance of Site quality policy.
To manage Quality Critical Event and ensure that event is escalated to the concerned party according to concerned global policy. To contribute as a member of quality critical event for reviewing of decision for the event such as continuing production and sales and level of recall etc.
Prepare and control of budget (CAPEx and OpEx) of quality department. Optimize year on year to reduce expenses and head count.
Review and approve all quality concerned investment to ensure that there is no quality and concerned regulatory impact.
Lead overall management of external regulatory inspection at the site.
To support key quality process during NPD/EPD roll out from site.
To support all key initiative at the site as key member of the Site leadership team.
Other responsibilities assigned by the management time to time.
We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
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