1.0 Objective
To lay down a procedure for Recruitment of Employees.
2.0 Scope
This procedure shall apply to Human Resource Department of pharmaceutical Industry.
3.0 Responsibility
3.1 Microbiologist shall responsible to follow the procedure mention in this SOP.
3.2 Head of Human Resource Department & QA Head shall be responsible for compliance of the procedure.
4.0 Accountability
4.1 Head of Human Recourse Department & QA Head shall be accountable for implementation of this SOP.
5.0 Abbreviations and Definitions
| SOP | : | Standard Operating Procedure |
| GMP | : | Good Manufacturing Practice |
| GLP | : | Good Laboratory Practice |
| HRD | : | Human Recourse Department |
| QA | : | Quality Assurance |
6.0 Procedure
6.1.1 At the time of recruiting any employee his qualification and experience in the job for which he is to be appointed shall be taken into consideration by the Human Resource Department.
6.1.2 Copies of the certificates of qualification and experience produced by the employee shall be kept as office record.
6.1.3 At the time of appointment of any employee he shall be directed to get himself medically examined by the Doctor approved by the company for this purpose.
6.1.4 Only if the employee is declared by the Doctor medically fit to carry out the job for which he is appointed, then the employee shall be allowed to serve the company. The original medical certificate produced by the employee shall be kept as office record.
6.1.5 The employee shall be issued a specific Appointment Code Number.
6.1.6 The employee shall also be issued a specific Swipe card for recording his attendance by the swipe card sensor machine at the start and at the end of the work by the employee in the manufacturing unit.
6.1.7 Every staff employee shall be provided with an appointment letter bearing his signature and that of the appointing authority of the company.
6.1.8 Every staff employees shall be served with a job description document indicating his job responsibilities during his stay with the company. This document shall be signed by the employee, Director or head of the Department and HRD manager.
6.1.9 All employees, including temporary employees, shall be given GMP training in the start of their service and periodically thereafter during their stay with the company as per SOP titled “For training of personnel”. This training shall be evaluated through Questionnaire.
6.1.10 Every staff employee shall be supplied with the handbook of company information, Quality policy and objective and Literature describing GMP. He shall be periodically given the following trainings every year during his stay with the company, in addition to the Induction Training given at the time of his appointment:
i) SOP Training
ii) On-Job Training
iii) GMP Training
iv) Industrial safety & Security Training
v) GLP Training for the staff working in Laboratory
vi) Need based Trainings when anyone requires
6.1.11 The training mentioned at S.No. i) To v) above shall be evaluated through Questionnaire and records shall be maintained as per SOP titled “For Training of Personnel” by the Q.A. Department.
6.1.12 It shall be the duty of every employee to intimate to his supervisory about his illness or abnormal health or open lesions which shall adversely affect the quality of the products.
6.1.13 It shall be the responsibility of the supervisor to disallow any employee who is unfit to perform his job responsibility due to apparent illness or open lesions on his body which are likely to affect the quality of the products and shall not be allowed to handle starting materials, packing materials, in-process materials and drug products until his condition is no longer judged to be a risk.
6.1.14 All the employees shall avoid direct contact of raw materials, intermediates, finished products and un-packed products with unprotected hands.
6.1.15 Prior to employment all personnel shall undergo medical examination, including eye examination, freedom from tuberculosis, skin and other communicable or contagious diseases. Thereafter, they shall be medically examined periodically, at least once a year and necessary records shall be maintained by the Human Resource Development.
6.1.16 All the employees, prior to and during employment, shall be imparted training to ensure personnel hygiene. A high level personal hygiene shall be observed by the employees engaged in the manufacturing processes.
6.1.17 All the employees shall wear clean body coverings appropriate to their duties.
6.1.18 It is mandatory for all the employees to observe dress code and wear uniform provided by the company.
6.1.19 Smoking, eating, drinking, chewing or keeping food, drink and personal medicine shall not be permitted in production, laboratory, storage and other areas where they might adversely influence the product quality.
6.1.20 Casual workers or Permanent workers engaged by the company to carry out the work of loading and unloading of materials shall not be allowed to enter and work in the production area.
6.1.21 The employees working in the maintenance department shall not enter the production area without wearing proper uniform.
6.1.22 Every employee shall be bound to follow the Company Policy and Rules & Regulations.
7.0 Forms and Records (Annexures)
Not Applicable
8.0 Distribution
Master copy – Quality Assurance
Controlled copies- Production, Human Resource Development
9.0 History
Date |
Revision Number |
Reason for revision |
– |
00 |
New SOP |
