Pharmaceutical Quality Assurance 15 Porsonnet Ideally a job description must contain knowledge about (i) Organisational position giving reporting relationships i.e. clearly mentioning, who reports to him and he will report: to whom ? (ii) Individual assignments, (ii) Job summary - what the jab entails, (iv) Working conditions, hazards of the job. (v) Duties, responsibilities and accountability. The regulatory authorities expect all important positions must have written, authorised and accepted job descriptions. (2) Key Personnel : Most regulatory guidelines define the key personnel and job descriptions of some of the key personnel. Key personnel can be defined as those positions in the organisation, which have a direct impact on the working of the organisation and quality of the products produced. Different regulatory guidelines have different positions mentioned as Key-personnel. Following is a brief matrix on the same. Sr.No. Positions India | UK | Aust. | WHO | SA | USA 01 _ | Head of Produetion = v v v v - 02 | Head of Q.C. = v ¥ v v - 03. | Head of @. A. = - - - v - 04 | Head of Sales and Distribution | — - - v - - 05 _| Authorised person = = = v - - 06 | Managing Director = - - - v - So totally there are six different key-personnel identified in regulatory literature but only two of these positions have been deseribed in detail i. head of production and head of @. C However other regulatory literature randomly mentions the importance of these positions without calling them key personnel. Now let us see the Job profiles af the two key-personnel deseribed in the literature. It is expected that all the key personnel should have appropriate qualifications and sufficient, suitable experience to carry out their responsibilities. The South African guide lines specifically lay down a requirement that the Managing Director of the Pharmaceutical Company should be a pharmacist residing in South Africa and registered with the Pharmacy Council (A) The Head of Quality Control He generally has the following responsibilities : (a) To approve or reject starting materials, packaging materials and intermediate, bulk and finished products, III O <