Quality Control

Staff requirements

Staff requirements 

To provide carrying out of the QC laboratory staff requirements.

This procedure is applicable to the QC laboratory staff.

PROCEDURE 

  •  Permanent staff is to work in the QC laboratory. It must be guaranteed that the staff is qualified, has the motivation, works, and is regulated according to the QC system requirements.
  • The staff is responsible for carrying out the requirements described in Job Descriptions.
  •  QC laboratory staff is to be educated, trained accordingly, and/or have practical experience in carrying out the functions and responsibilities. The management is to guarantee the qualification of the staff.
  • Laboratory staff responsibilities are to be defined exactly and set out in writing.
  • It must not be any of conflict of interests and pressure that may influence the quality of the received result.
  • Every employee of the laboratory is to have the qualification card with a name, surname, position, education, and information about taking the extension courses (the document which confirms taking the extension courses, if it is available).
  • Employee progress, training, change, and career development are carried out according to the results of his/her work, qualification, skills, interests, and laboratory requirements.
  • Permanent training and professional development of the staff are to be provided on-side (by qualified specialists) and off-side. For this purpose, one collects information about seminars and conferences of quality control, certification, and standardization.
  • Internal training is carried out by qualified specialists of the laboratory according to the staff training plan.
  • For tracing of the staff work and training effectiveness one is to complete the training records and from time to time conduct testing. This system favors the correctness of introduced mistakes or drawbacks.
  • Staff is to keep the sanitary code, wear clean proper working clothes, and shoes, and should not have pernicious habits.
  •  Before employment the staff is to have a medical:  immunization, roentgen logical examination, skin test, and test for antibodies (as necessary). The staff should have medical exams at least once a year.

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Alvina

Alvina is the Author and founder of Guidelinepharma, she is a pharmaceutical professional having more than 20 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube