Delta Pharma Limited
Delta Pharma Limited is one of the faster growing company with an aim to reach the level of excellence through a sustained effort and with truly professional environment. To achieve our goal, we require young, energetic, self-motivated, hardworking individuals for the below position:
Position: Head of Quality Compliance
Assurance and enforcement of cGMP in production, quality control, warehouse, engineering facilities. On time Management of compliance activities like risk management, CAPA management, deviation, change control, market complaint, returned goods management, self Inspection, internal & external audit etc
Preparation & implementation of SOP’s, Protocol, SMF, VMP, DMF, CTD & eCTD, Quality Manual, APQR, QMS related documents and other quality documents.
Ensuring calibration, process validation, analytical method validation, cleaning validation, vendor validation and qualification of machinery, equipments, HVAC systems, compressed air system, purified water system, steam system and effluent treatment system.
Preparation of training module and conduct GMP training and others training for the relevant factory personnel.
Preparation and update of specifications of raw materials, packaging materials and finished products.
Ensuring physical, chemical & biological tests of raw materials, intermediates, bulk and finished products of all dosage forms, dispensing of raw materials, release & rejection of raw materials, packaging materials and finished products.
To evaluate proper batch documentation system, reviewing data, assessing & solving the problems.
Identification of the part of the process where in process control check are required and its implementation.
Monitoring and control of the manufacturing environment and plant hygiene.
Responsible for release the batch of product for marketing.
Fulfillment of regulatory requirements of home and abroad.
Assist the Executive Director (Plant) to develop quality standards, rules & regulations and accomplish the goals and strategic plans.
Coordination with Quality assurance, Quality Control, Product Development, R&D, Production and Engineering Department for proper support in all quality related matter/activities.
Conducting any type of inspection by ISO and others Regulatory bodies from home & abroad. Completing the inspection report according to inspected results.