Reckitt Benckiser Group plc (RB) is a British multinational consumer goods company headquartered in Slough, England. It is a producer of health, hygiene and home products.[4] It was formed in 1999 by the merger of the UK-based Reckitt & Colman plc and the Netherlands-based Benckiser NV. They are a 37, 000 entrepreneurs, all inspired by a vision of a world where people are healthier and live better. At the heart of our rapidly growing consumer health business is a passionate desire to help people feel better. They invest in research and development to find new ways for people to look after themselves, their families and homes. They believe there’s a better way to do business – we like to call it ‘betterbusiness’. Socially, environmentally and financially, we act responsibly and sustainably.
Job Title: Assistant Manager – Ongoing Stability and Laboratory Compliance
Salary: Not disclosed by the employer.
Job Description:
- Ongoing Stability and Laboratory Compliance role holder should work in a challenging analytical environment, to ensure the stability requirements for the commercial products and in parallel to ensure the compliance levels within the laboratory in line with current regulatory expectation.
- Job holder should make sure the compliance data integrity in the laboratory.
- The role involves delivery of Ongoing Stability for licensed products manufactured at local factory.
- The role holder is responsible for the management of the Ongoing Stability and Laboratory Compliance team, the laboratory and the stability storage facilities. Also, the role involves a wider scope in upgrading the compliance level within the analytical laboratory including the R&D functions.
- The role holder is responsible for liaising with the QA, QC, Technical, HME and R&D Category for product quality incidents (QIRs)
Job Responsibilities:
Functional
- Responsible to develops and executes risk assessments and reviews of compliance risk areas to determine need for improvement often in consultation and coordination with internal and external audit groups.
- Designs and performs or coordinates compliance monitoring activities.
- Responsible to the local QP Team for the delivery of Ongoing Stability.
- Accountable for data generated and that it is reported to cGMP requirements and represents “real time”. Data must be analyzed (including trend analysis), conclusions drawn and communicated to QPs and R&D teams.
- Anomalous results may need to be reported to Regulatory Authorities as per applicable procedures.
- Accountable for Ongoing Stability program in audits and inspections.
- Accountable for ensuring that laboratory investigations are thorough and accurate.
- Promote business interests.
- Accountable for execution and management of the Ongoing Stability studies in compliance to regulatory guidelines.
- Accountable for management of the Stability chambers in compliance to regulatory guidelines.
- Responsible for review of Trend charts, APSR reports of stability testing.
- Liaise with Development R&D teams to understand and interpret data.
- To ensure the Laboratory practices are in compliance with written procedures and guidelines.
- Accountable for QMS activities in laboratory and to enhance the audit preparedness in laboratory.
- Develops and delivers training in compliance risk areas and regarding RB policies.
- Undertake quality activities (as required) such as internal audits in line with a defined schedule.
- Day to day team management, including issues, resourcing and PDRs.
- Monthly reporting of team performance against KPIs.
Cross Functional
- Works closely with the QA, QC, Technical and R&D teams to facilitate product launch.
- Facilitation of quality reviews with key members of the R&D category development and RSE teams.
- Liaise with other functions to generate annual stability programs, stability protocols etc.
- Liaise with other functions to ensure appropriate CAPA are in place for the observations of internal or external inspections
- Liaise with other functions to achieve maximum compliance level in laboratory as per regulatory requirements.
Qualifications:
Essential:
1. M Pharma, B. Pharma or MSc (Chemistry) Degree.
2. Should have faced MHRA, USFDA, WHO audits
3. High level of familiarity with broad range of compliance risk areas, relating to regulatory authorities such as USFDA, MHRA, WHO etc.
4. Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action (a thinker and an achiever).
5. Ability to recognize trends in data and identify outliers.
6. Good IT skills, & knowledge of LIMS, SAP
Desirable:
1. Experience within the healthcare industry is desirable, particularly in a practical / analytical area to GMP/GLP standards.
2. Knowledge/ understanding of key quality related regulations i.e. Drugs and cosmetics act, Pharmacopoeia, ICH, WHO, MHRA, USFDA GMP etc.
3. Experience of leading or managing a group of people with strong communication, presentation and training skills.
