Executive EMO Quality
We are Reckitt
Research & Development
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
About the role
The overall purpose of the job is management of Health EMOs by ensuring the quality of Reckitt- Benckiser
products leading the factory by the conceptualizing, implementing, improving, and auditing the most
economically efficient Quality system, in line with Global Quality Policy/Manual, the Global, Regional, and
local procedures and the requirements from Schedule M, WHO, MHRA, EU, USFDA, Russian Federation
and any regulatory authority.
To ensure that the activities carried out at India DC’s are compliant to all regulatory requirements for
healthcare and hygiene products, as described in Reckitt Quality Manual and Reckitt Distribution procedure
Your responsibilities
Using risk-based methods to approve new and maintain ongoing approval and quality status of 3rd
party External Manufacturing Organisations (EMO’s) that manufacture and supply product to
Reckitt Healthcare group of companies.
The EMOs are approved as compliant with relevant regulations and Reckitt’s requirements. This will
be ensured through their own activities and through that of their direct and indirect team
that:
Conduct assessments and audits in accordance with RECKITT policies and procedures.
Quality issues arising from EMO’s are managed promptly in accordance with regulations and Reckitt
requirements.
Support other Reckitt functions with quality activities relating to new finished product
introductions and site transfers into EMO facilities and for the renewals of existing products as
required.
The development and delivery of EMO audit and approval plans.
Overseas, the collation of appropriate metrics to monitor the performance of the team, with
submission of these metrics as required by Reckitt procedures.
Conduct assessments and audits in accordance with Reckitt policies and procedures.
EMO Audit Risk management for all Health active EMOs.
Through routine audit, Technical agreements and regular contact ensure EMO’s activities are fully
compliant with relevant regulatory and Reckitt guidelines to minimise risk to consumers, the
company and applicable brand name.
Leading product launch through the GFS certification as per the procedure in place for the
product launch -
Ensuring review and approval of Technology Transfer documents at each stage
Ensuring availability of valid PSER /PSDS
Ensuring Validation activities i.e. protocol/report review, approval.
Review of all GFS batch documents i.e. BMR, BPR, FG analysis, RM and PM records.
Review and approval of deviations if any.
Ensuring review and approval of Transit trials Review/approve QMS KPIs on monthly basis not
limited to Change control, Deviation process, Batches mfg./released, complaints, AQLs, OOS,
related to Reckitt’s products at external Manufacturer.
Resolution of quality issues that may affect consumer safety, regulatory compliance, customer
satisfaction and operational performance.
Performance of Health checks of internal systems and reporting of KPI, Project Status and other reporting wherever necessary.
The experience we're looking for
TDS documents approval for RM, BOM, and Specification etc.
• AQL approval at external Manufacturer.
• To approve the validation programme and provide analytical services for Process validation.
• Audit and control of 3rd party’s quality performance & DCs to Reckitt, including but not limited
to finished product contractors, active ingredient suppliers, raw material, and component supplier.
• Management of EMO raised Change controls, Deviations – including documentation on Quality
one.
• Maintenance of Consumer complaints system – co-ordinating between the Consumer Relations
Reckitt team and the EMOs/ DCs or other Reckitt functions supporting investigations.
• Training of the EMO’s for CGMP & Data integrity in alignment with Reckitt expectation.
• To ensure the management review and annual product review program are maintained according
to concerned GMP and QMS requirement.
• Support in overall management of corporate audits.
• Sharing good practices across EMOs & DCs for continuous improvement.
• Responsibility is to closely work with Supply services team to ensure quality and compliance right
at first time at DCs. Aim is to drive a sustainable culture at DCs.
• To identify the training requirements of personnel and execute upskill plans to sustain third party
operation is in line to Reckitt Quality requirements. Impart Training to EMO & DC personnel from time to time as required
The skills for success
What we offer
Equality
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