Job Description

Title: Assistant Manager, Quality Control

Company Name: DBL Pharmaceuticals Ltd. (A Concern of DBL Group)

Vacancy: Not specific

Job Location: Gazipur

Employment Status: Full-time

Educational Requirements:
∎ M. Pharm or M. Sc in Chemistry, Applied Chemistry, Bio-Chemistry and Molecular Biology from reputed university.

Experience Requirements:
∎ 8 to 10 year(s)
∎ The applicants should have experience in the following area(s): Quality control
∎ The applicants should have experience in the following business area(s): Pharmaceuticals

Job Responsibilities:
∎ Should have the Capability to handle a group of people, with suitable coordination and timeline commitments, target achievement orientations, through strategic planning and smart decisions/discussions. Training of newly joined Chemists.
∎ Overall responsible for analysis of Raw Material, Packing Material & Finished Goods.
∎ Provide technical and general information to all subordinates followed by necessary training in all categories to build a skilled and knowledgeable QC team.
∎ Thorough knowledge of analytical instruments handling like HPLC, GC with auto sampler and HS, PSD, AAS, Auto-titrator, IR and others, preferably knowledge of ICP-MS, XRD, DSC, TGA etc.
∎ Ability to handle the management of vendor approval, OOS, OOT, Deviation, CCR, LIR, calibration and qualification, analytical method tech transfer etc.
∎ Supervise, review, draft and compilation of documents such as stability protocols, finished and raw material specifications, method of analysis, transfer protocol, transfer report, SOP etc.
∎ Should have sound knowledge on Method Validation, Method verification, Method transfer, Cleaning validation and updated Guidelines and standards.
∎ Supervise the preparation, execution and completion of IQ/OQ/PQ of new instruments and also EOP and ECP preparation.
∎ Ensure proper inventory control of QC instruments, spare-parts, glass-wares and reagent/chemicals to control stock and availability in the QC lab.
∎ Ensure all the necessary tests and approve the commercial, specimen raw materials, finished products and packaging materials to QC release properly to fulfill marketing demand in time.
∎ Ensure the stability study as on ICH Guideline to establish product shelf-life and to meet the regulatory requirements.
∎ Investigates non-compliance situations in order to determine cause and initiate corrective action.
∎ Implements appropriately qualified laboratory procedures to ensure compliance with safety, cGMP and GLP regulations.
∎ Review and updating the analytical data to maintain cGMP/GLP compliance status in the laboratory.

Additional Requirements:
∎ Experience in Regulatory Inspections.
∎ Strong knowledge of GMPs guideline /GLP/GDP/ regulation / (WHO, UKMHRA, FDA, 21CFR part 11 etc.)
∎ Ability to inspire, lead, and develop people in a multi-cultural environment, establishing an atmosphere of mutual respect.
∎ Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
∎ Experience on SAP/ERP system and other data analysis.
∎ Strong personal & professional ethical values are essential.

Compensation & Other Benefits:
∎ We offer excellent work environment, attractive compensation package and performance-based career progression.

Application Deadline: 25 Jul 2020

Company Information:
∎ 16 Jul 2020
∎ DBL Pharmaceuticals Ltd. (A Concern of DBL Group)
∎ Address : Capita South Avenue Tower, 6th Floor House No # 50, Road No # 03, Gulshan Avenue Gulshan 1, Dhaka - 1212, Bangladesh
∎ Web : dblgroup.taleo.net/careersection/ex/jobsearch.ftl

Category: Medical/Pharma

Source: bdjobs.com

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