Nipa Pharmaceuticals Ltd.

Summary

Vacancy: —
Age: 30 to 45 years
Location: Dhaka
Salary: Negotiable
Experience: 5 to 10 years
Published: 7 May 2024

Requirements

Education

Master of Science (MSc) in Pharmacy

Must have Pharmacist registration

Experience

5 to 10 years
The applicants should have experience in the following business area(s):
Pharmaceutical/Medicine Companies

Additional Requirements

Age 30 to 45 years

Responsibilities & Context

Organize and carryout analytical activities of raw materials, packing materials and finished products and to ensure quality of product by implementing guidelines of WHO, ICH, FDA, TGA, etc.
Perform in process Checking, BMR, BPR and SOP’s preparation and checking during manufacturing of products.
Participate in all qualification and validation activities.
Ensure proper documentation of all quality assurance related documents.
Ensure other activities like environment control, water sanitation, waste disposal, HVAC system validation, and ETP, housekeeping, health & personnel hygiene.
Ensure required Training of QA/QC/Production/Engineering/Ware house personnel.
Maintain all Compliance related activities and documentation.
Would be a plus if familiar with dosser preparation for International market and other export related work.
Responsible for all In Process Quality Assurance activities (IPQA) on the shop floor including quality oversight and Batch record review.
Responsible to perform SAP (SHAPE) activities in the QM Module and will be the part of Deviation Management, investigation of market complains and other compliance activities.
Sampling & Analysis of Raw Materials, Packaging Materials, Finished Products and Water.
Handling of all sophisticated QC instruments like HPLC, GC, UV-VIS, FTIR, TOC, Dissolution tester, Karl fisher autotitrator & Disintegration tester etc.
Preparation and review of SOPs, specifications & methods for raw material, packaging material & finished product etc.
Validation of analytical methods, Cleaning & Qualification of equipment’s.
Preparation & standardization of volumetric solution, secondary working standards from reference standard etc.
Calibration of all sophisticated QC/QA equipment’s.
Handling of OOS with proper investigation.
Maintain GLP & housekeeping and make corrective measures for any deviation. Broad experience dealing with Regulatory Bodies Excellent Leadership and communication skills.
Expert user of MS Word, MS Excel and Power point presentation.
Analytical abilities, creativity, innovative ideas and a self-driven attitude; should possess a strong presence of mind combined with problem solving and decision making skills.
In depth knowledge of handling HPLC, IR, GC, AAS etc.
Knowledge on GMP, GLP, Calibration & Validations, Drugs Rules & Regulations.
Knowledge on stability testing.
Knowledge on national health policy.
Ability to work under stress.

Skills & Expertise

Computer skill

QAQC Documentation

QC & Compliance

Workplace

Work at office

Employment Status

Full Time

Job Location

Dhaka

Source link

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