Quality Assurance

Procedure for personnel management system

Purpose : To lay down a procedure for personnel management system.

SCOPE : This SOP is applicable to the Human Resource Department.

RESPONSIBILITY : Head Human Resource and Management.

ACCOUNTABILITY : Quality Assurance Head

ATTACHMENTS : Not applicable

PROCEDURE:

Personnel department will lay out the personnel management system which includes identification of staff position, the responsibilities and power of staff in accordance with the company’s organizational structure, work rules in the organization

RECRUITMENT PROCEDURE 

All the Department heads will prepare the list of required staff along with the Job Specification

HR Head will prepare the Job Responsibilities and will ask the recruitment agencies for the required candidates

On receiving the resume of the candidates from the recruitment agency, HR Head along with respective departments will shortlist the candidates.

HR Head will than call the suitable candidates on the date fixed for the interview

After interview the HR Head and Department Head will select the candidate.

HR Head will send the candidate the appointment letter

TRAINING OF PERSONNEL

To train all the employees working in the areas, associated directly or indirectly with manufacturing.

To create an awareness of GMP and specific job related technical skills in the employees

SOP Training and GMP training must be given to all employees to ensure that employees are familiar with current GMP requirements and have the knowledge and skill necessary to perform their assigned duties and responsibilities.

Three types of training programs shall be conducted :

  1. a) Induction / Orientation training
  2. b) SOP training
  3. c) GMP / General Training

Induction and Orientation Training

Every new employee must be given induction training with a view to facilitate entry into the organization and to acquaint him / her with the systems and procedures applicable to him / her

Induction training will be given by HR department. SOP and GMP training will be given by QA / Respective department.

Personnel

Every new employee must be introduced to fellow staff members and made aware of the :

а) Company’s History

  1. b) Company’s Policies
  2. c) Sanitation and Cleaning etc.

GMP Training

GMP Training must be imparted by means of classroom Training and should cover, but should not be limited to, the following topics :

а) Personnel Hygiene

  1. b) Documentation
  2. c) Sanitation and cleaning etc.

SOP Training to the New Employees

Every new employee must be asked to read and understand all the SOPs applicable to him

Department Head must evaluate the employee by asking questions orally/written and if found satisfactory, department Head must sign and date SOP Training Record All critical SOP Should be evaluated in written.

If not found satisfactory, department head should explain the SOP and re-train the employee.

SOP Training

SOP Training is imparted at following stages :

  1. On Inter Department Transfer
  2. Revision in the SOP’s or introduction of any new SOP.

The employee shall read all the SOP’s concerned to his job function, before work is assigned to him / her by whom he can come to know about the various procedures related to his functional skills. (The language of SOPs will be English, Hindi).

After the employee has read and understood the SOPs, he shall be trained on the shop floor by his immediate supervisor for the clear understanding of the job assigned to him

Department Head must evaluate the employee by asking oral questions and if found satisfactory, department Head must sign and date SOP Training Record. All critical SOP/Operations should be evaluated in written

If not found satisfactory, department head should explain the SOP and retrain the employee

Department Head must sign the Training Record and hand it over to QA department (Training Coordinator).

Training Coordinator preserves the record

GMP Training

GMP Training is to be given to all employees to create GMP awareness amongst all employees

After completion of training, trainee must be evaluated by providing a questionnaire.

Trainee must write the answers in the stipulated time period.

Training evaluates the answers given by trainee and awards the marks.

Criteria for evaluation

% Marks ObtainedRemarks
< 70 %Requires additional training

Unsuccessful candidates must be retrained immediately

Coordinator must maintain Employee training Record for the individual employee

Refresher training on GMP shall be provided to all employees on yearly basis.

Medical Examination

Medical examination has to be done  by a qualified Medical Practitioner

All the employees are routinely checked annually and state of health of employees reviewed. As recommended corrective action is taken.

Employees are advised to report voluntarily sickness including sickness of their family members. All the employees are advised to produce fitness certificate before resuming to work.

Any employee with open wounds, infectious diseases is not allowed into the factory until they are certified as cured by a medical examiner

 

 

 

 

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