Title: Sr. Manager/ Assistant General Manager, Engineering (Maintenance & Utility)
Company Name: The IBN SINA Pharmaceutical Industry PLC
Vacancy: --
Age: Na
Job Location: Gazipur
Salary: Negotiable
Experience:
The applicants should have experience in the following business area(s): Pharmaceutical Companies.
Maximum age 40 years.
Age and position may be relaxed in case of deserving candidates.
Establishment, implementation and maintenance of GMP-compliant engineering and facility management system.
Ensuring qualification, validation and lifecycle management of facilities, utilities and equipment (HVAC, water systems, compressed air, gases, electrical systems, etc.).
Planning execution and control of preventive, breakdown, and predictive maintenance activities.
Management of calibration, monitoring and control of critical instruments and utility parameters.
Planning and execution of GMP-compliant engineering projects, renovation, expansions and new installations.
Ensuring GMP-compliant facility and equipment design, layout, material/personnel flow, and contamination control.
Oversight of change control, deviation management and CAPA related to engineering utilities and projects.
Preparation, review and approval of engineering SOPs, URS, DQ, IQ, OQ, PQ protocols, reports and maintenance records.
Application of Quality Risk Management (QRM) principles in engineering and project activities.
Ensuring training, qualification and GMP awareness of engineering and project personnel.
Support to validation activities, internal audits, self-inspection and regulatory inspections.
Ensuring data integrity, documentation accuracy and logbook compliance for engineering systems.
As per company rules.