Executive, Validation

Job Description

Title: Executive, Validation

Company Name: Opsonin Pharma Limited

Vacancy: --

Age: At most 32 years

Job Location: Barishal

Salary: --

Experience:

• 1 to 3 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
• Freshers are also encouraged to apply.

• Bachelor of Science (BSc) in Mechanical Engineering, Electrical & Electronic Engineering

• 1 to 3 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
• Freshers are also encouraged to apply.

• Age At most 32 years

• 1–3 years’ experience in Qualification, Engineering or Validation in pharmaceutical or sterile manufacturing environment.

• Understanding of cGMP & qualification protocols

• Knowledge of HVAC, water system and utilities

• Familiarity with EU GMP Annex 1, 11 & 15 and validation lifecycle

• Good technical documentation skills

• Knowledge of FDA/WHO/EU GMP guidelines (advantage)

Opsonin Pharma Ltd. is one of the pioneers in the pharmaceutical industry of Bangladesh. At present Opsonin is enjoying its position as the fastest growing organization among the top Pharmaceutical companies in Bangladesh. Currently we are seeking application from qualified professionals
Major Job Responsibilities:

• Plan and ensure qualification activities for critical equipment, utilities, HVAC, clean rooms, compressed air, water systems and associated systems based on approved qualification plan and schedule

• Review and follow qualification Matrix for equipment, instruments and utilities used in Production, Engineering, QC and QA areas

• Make qualification protocols, SOPs, user requirements (URS) and review FAT/SAT, IQ and OQ of all types of equipment, facilities and utilities.

• Ensure periodic qualification and requalification of utilities and equipment based on lifecycle and risk assessment

• Collaborate and participate during commissioning and qualification activities with Engineering, QA, QC and vendors

• Ensure proper data integrity (ALCOA++) and documentation throughout qualification lifecycle

• Support internal, customer and regulatory audits by providing qualification documents and technical information

• Follow and maintain Quality Management System (Deviation, Change control, CAPA)