Officer, Validation

Job Description

Title: Officer, Validation

Company Name: Opsonin Pharma Limited

Vacancy: --

Age: At most 30 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.

• Diploma in Engineering in Mechanical Engineering, Electrical & Electronic Engineering, Industrial 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 30 years

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

• Knowledge of basic qualification concepts

• Familiarity with HVAC or utility systems in pharma (preferred)

• Ability to operate technical instruments and collect data

• Understanding of cGMP and data integrity principles

• Strong documentation and coordination ability

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:

• Perform qualification of equipment, HVAC systems, LAF, biosafety cabinets, pass boxes and utilities as per approved Validation Master Plan (VMP) and qualification schedules

• Operate qualification instruments including multichannel gas detector, oil bath, standard digital thermometer, PAO aerosol photometer, anemometer and air flow hood during HVAC and clean air equipment qualification

• Assist to execute thermal qualification of warehouse areas, chambers and equipment using wireless data loggers including program setup, data exposure, data downloading and documentation

• Follow qualification protocols, approved procedures and data integrity requirements (ALCOA++) during execution and documentation

• Compile qualification records and reports based on collected data and observations

• Identify necessary adjustments to equipment or parameters and report findings to senior validation team

• Carry out proper handling, validation compliance and maintenance of qualification instruments and tools

• Support audit readiness by maintaining qualification files, raw data and records according to cGMP and regulatory requirements