Head of Quality Assurance

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

Research & Development

In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

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 scope of the job includes planning and managing, day to day QA oversight activities.
• Ensuring on time release of products from Mauripur – Healthcare/ Household after proper review.
• Support SQH in Quality resource management, update system and documents as per requirement.
• Direct reports include:

Your responsibilities

• Authorized by Reckitt for taking final decision on release or rejection of finished products in conjunction with SOP HCQA-017.
• Authorized to delegate release or rejection of finished products including but not limited to as per Quality Assurance System defined under Schedule B-II GMP compliance of Drug Act 1976.
• Authorized by Reckitt in reference to Drug Act 1976, Drug (Licensing & Advertising) Rules 1976 & Schedule B-II to release & certify or to delegate release & certify that each production batch has been produced and controlled in accordance with the requirements of the good manufacturing practices and the relevant rules made under the Ordinance relevant to the production, control, and release of drugs as well as of conditions of registration.
• Establish the quality management system and procedures.
• Monitor adherence to QA process is following all local regulatory requirements and Reckitt quality management systems.
• Ensure that the quality control procedures are implemented during every step of the production process.
• Implement Product Quality plans to ensure controls of manufacturing, quality testing and product packaging through line inspection.
• Implement Product Validation second plan to ensure robustness of manufacturing process, equipment, cleaning, and environment.
• Ensure that Annual Product Review (APR) are prepared and CAPA plan is in place.
• Ensure that thorough checking of batch documents in order to ensure release of Finished Products for sales is done in compliance with all local regulatory requirements and Reckitt Quality Management System.
• Plan and conduct internal quality audits and facilitate proactive solutions by collecting and performing statistical analysis of quality data.
• Establish and implement the Inspection and Testing Plan
• Participate in GMP Audit Program for the site.
• Ensure that deviations system is in place and effective CAPA and investigations are being done and monitor progress on implementation of CAPA.
• Ensure that Change control procedures are in place and effective.
• Take appropriate corrective actions on identified problems.
• Identify potential sources of error and suggest ways to eliminate them. (Preventive Actions)
• Support in investigating customer complaints.
• Ensure to manage proper upkeep and maintenance of Batch history records / documents and finished products and raw material retention samples.
• Monitor and report KPIs and take corrective / Preventive actions to improve quality performance.
• Continuous process improvement Devise procedures to inspect and report quality issues.
• Carry out regular Quality reviews with Supply Leadership to highlight areas of risk, progress being made, help needed and learning to be transferred smoothly.
• Ensure that NPD/EPD projects are smoothly handed over into manufacturing operations while ‘Good-For-Sale’ is only approved when all quality requirements and success criteria are satisfied.
• Any other job/task assigned by Site Quality Head.
  
   

The experience we're looking for

• Doctor of Pharmacy (Pharm – D) or bachelor’s degree in pharmacy with 7 years experience having minimum five years experience in quality control and testing of drugs.
• Additional business high school graduation degree e.g., MBA/ MPhil will be preferred.
• Clear understanding and ability to assess and act upon product safety, quality, efficacy, and compliance risks.
• Good understanding of typical regulatory requirements relevant to a regulated product (But not limited to) e.g., Drugs Act. 1976, DRAP Rules 2012, ISO Standards and applicable ICH guidelines.