Commercial Quality Associate / Responsible Person for Narcotics (Fixed term)
We are Reckitt
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 primary responsibility of the Commercial Quality Officer & Narcotics RP (Health) is to provide leadership for excellence in Quality and Compliance of all Health products and processes within the supply/distribution chain, including embellishment.
Your responsibilities
- Comply with the requirements under national law on narcotic drugs of the narcotics (III-N group) - Pharmaceutical Law and the Act on Counteracting Drug Addiction in the area of narcotic drugs of the III-N group.
- Ensure the distribution of narcotic drugs of the narcotics (III-N group) in a manner that protects them against theft or unauthorized access.
- Provide training to employees dealing with the service of the narcotic drug depot.
- Qualify suppliers and recipients of narcotic drugs of the III-N group.
- Arrange for the consent of the Chief Pharmaceutical Inspector for the intra-Community acquisition of narcotic drugs of the III-N group.
- Supervise the observance of procedures in the scope of activities regarding acceptance, storage, completing, issuance, withdrawal, redistribution, disposal and transportation of narcotic drugs of the narcotics (III-N group).
- Documenting and investigating deviations from established procedures, and if applicable taking appropriate corrective and preventive measures to removing exemptions and preventing them in accordance with the principles of quality risk management.
- Provide the Health Authorities with information on the volume of trade in the narcotic drugs of the III-N group, in accordance with local regulations (reporting on monthly and yearly basis).
- Entrust a replacement and transferring tasks in accordance with the applicable procedure.
- Observe the Work Regulations and safety rules for health and safety and fire protection.
- Carry out the current recommendations of the superiors according to the ethics of the profession of pharmacist.
- Cooperate with Commercial Quality Manager to ensure robust and effective QMS doe medicines, including Narcotics.
- Corporate with GDP RP and act as back up in case of absence and/or as support.
Accountabilities:
- Act on behalf of the entity responsible for issuing the authorization of the Main Pharmaceutical Inspector for the intra-Community acquisition of narcotic drugs of the III-N group.
- Represent the Company towards the Pharmaceutical Inspection, to the extent specified in a permanent or one-time authorization, in the scope of narcotic drugs of the III-N group.
- Represent the Company towards the clients of narcotic drugs of the III-N group.
- Provide the Pharmaceutical Inspection Authority with records of the income and use of narcotic drugs of the narcotics (III-N group).
- Participate in training in the field of narcotic drugs group of the III-N group.
- Access to data on a computer system also on days off and outside of working hours (the need to take immediate action in the event of launching the withdrawal process).
- Autonomy in decision-making within distribution and wholesale activities.
The experience we're looking for
- Master's degree, pharmaceutical education.
- At least 2 years’ experience working in Pharmacy and/or Wholesale Distribution to ensure distribution of narcotic drugs group of the III-N group (narcotics).
- Experience in developing and maintaining a robust QMS in a Healthcare, Hygiene, Pharmaceutical, or Medical Device related industry.
- Clear understanding and ability to assess and act upon product safety, quality, efficacy and compliance risks.
- Understanding the role of the local competent authority in the licensing of medicines.
- Good understanding of regulatory, GMP and GDP requirements relevant to a regulated product e.g. EU GMP, EU GDP, WHO, PIC/S, CFR 21 Part 210/211 any additional local regulation for medicines and narcotics.
- Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.
- Influencing skills in areas with no direct reporting authority.
- Strong interpersonal and communication skills.
- Auditing skills, appropriate qualifications in auditing an advantage.
- Fluent Polish and communicative level of English (minium B2 level).
The skills for success
What we offer
Equality
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