Responsible Person

Employer
BAP Pharma
Location
Slough, Berkshire
Salary
Negotiable base, plus bonus
Closing date
9 Oct 2020

View more

Discipline
Quality, GMP, Qualified Person, Project Management, Quality Project Management
Hours
Full Time
Contract Type
Permanent
You need to sign in or create an account to save a job.

We are looking for someone to join our growing company as a Responsible Person with the opportunity to grow in the role who will ensure that BAP Pharma is compliant with MHRA guidelines concerning medicines & Home Office guidelines for Controlled Drugs.  

You and the team will safeguard product users against potential hazards arising from poor distribution practices and to be knowledgeable of UK and EU legislation.

Responsibilities

  • Check ALL goods received are not counterfeit medicines, by looking for evidence of tampering or anything suspicious. Check product description, quantities, expiry dates, batch numbers are accurately recorded and match POs
  • Checks to be carried out by using pre-prepared template on clipboard per product arrival
  • To ensure goods that have been delivered by bona fide suppliers are to a high standard 
  • Ensure damaged goods are returned to the supplier or destroyed by the appropriate contracted company
  • To check that goods supplied damaged by BAP to clients are destroyed responsibly by client before issuing a credit note as described in SOP procedures
  • For cold chain products ensure goods have been maintained at 2-8°C by checking temp traces and storing them in the RP database, clearly labelled
  • Be completely familiar with BAPs stock control system Orderwise and ensure goods are booked in accurately
  • Ensure that the conditions of the wholesale dealer’s license are met, and the guidelines of Good Distribution Practice are complied with
  • To print off stock report on a weekly basis from Orderwise ensuring the accuracy of the report and keeping the MD informed
  • To anticipate goods arrival by printing weekly orders on the system keeping the MD informed of any deviations
  • Check that Warehouse and Cold Room temps are kept between the parameters on a daily basis Cold Room 2-8°C, Warehouse 8-25°C
  • Ensure that SOPs are up to date and reviewed on a regular basis
  • To add any SOPs as relevant, train employees to ensure compliance and understanding
  • Liaise with the MHRA and Home office as and when necessary. To be present for any visits by the MHRA and/or Home Office
  • Liaise with QP for goods arriving from outside the EU
  • Check that the temp probes are serviced and calibrated annually and records kept
  • Keep a record and store supplier’s WDL
  • Understand the workings of various shippers, e.g. Credos and Sherpa’s so that if there is a temp excursion a rational explanation can be given to the client
  • Keep an accurate record on the RP database of all temp traces
  • Ensure that the activities of the company are properly reflected in the Wholesale Dealer’s Licence
  • Ensure that the provisions of the Wholesale Dealer’s Licence are observed
  • Ensure that the operations do not compromise the quality of medicines
  • Ensure that an effective quality system is implemented and maintained
  • Ensure that adequate records are maintained for a period of 5 years
  • Ensure that all personnel are trained to carry out their respective duties
  • Ensure full and prompt cooperation with marketing authorisation holders in the event of recalls
  • Oversee audit of the quality system and to carry out independent audits
  • Ensure that appropriate standards of GDP are maintained

Essential skills and experience

  • Knowledge of The Medicines Act 1968
  • Knowledge of Eudralex, The Rules Governing Medicinal Products in the European Union, Volume 4 Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use
  • Good Understanding of the Wholesale Dealer’s Licence
  • Knowledge of, The Human Medicines Regulations ( UK SI 2012 1916)
  • Understanding of Directive 2001/83/EC as amended, of the Community Code relating to medicinal products for human use
  • Understanding of, The New Guidelines for Good Distribution Practice of medicinal products for human use
  • Knowledge of Commission guidelines for GDP of medicinal products for human use (2013/C 68/01)

BAP Pharma – clinical trial supply of comparator drugs

BAP Pharma are specialists in the clinical trial supply of comparator drugs, with a global reach. We have extensive experience both in Europe and worldwide. With over 50 years in the industry we are well-placed to understand your clinical trial supply needs, and our long heritage means that we can truly deliver on our promise:

Promise delivered

“If you need a leading partner for clinical trial supply of comparator drugs, to give you peace of mind that your clinical trial will progress with the right quantity, of the right product, in the right condition, at the right time –  you’re in safe hands”.

Mission statement

To become the global leader in the supply of comparator products, known for our innovation, expertise, ethics, and dedication to providing excellent customer service.

Please visit our Careers Hub 

Contact Us
  • 103 Buckingham Avenue
  • Slough
  • SL1 4PF
  • United Kingdom
  • +44 (0)1753 696326
  • Mini-site: BAP Pharma
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert