Title: Assistant or Deputy Manager, Quality Assurance
Company Name: Silva Pharmaceuticals Limited
Vacancy: 1
Age: 30 to 35 years
Job Location: Noakhali
Salary: Negotiable
Experience:
Having the A-Grade Registration of Bangladesh Pharmacy Council (BPC)
Excellent working knowledge of global GMP regulations, ICH guidelines and robust Quality Systems.
Broad experience in the pharmaceutical industry with a strong analytical and / or manufacturing background and well conversant in MS Office.
Good interpersonal and communication skills.
Candidate must possess excellent planning & execution skills as well as strong quantitative & qualitative analytical skills.
Strong personal & professional ethical values are essential for the position.
Capable to work in a team and in shifting environment.
Experience in establishing and implementing QMS for a new greenfield or brownfield pharmaceutical facility.
Competence in reviewing URS, DQ, FAT/SAT, IQ/OQ/PQ protocols and reports for equipment and utilities.
Experience in layout review, material and personnel flow assessment, and GMP risk identification for new facilities.
Provide QA oversight of commissioning, qualification, and validation (equipment, utilities, process, cleaning, and analytical).
Excellent communication, coordination, and problem-solving skills suitable for a fast-paced project setup.
Ability to work cross-functionally with engineering, production, QC, and validation teams during project and operational phases.
Hands-on, proactive, and detail-oriented approach with the ability to handle multiple project activities simultaneously.
Ability to develop, review, and approve SOPs, SMF, VMP, MBR/BMR, specifications, and other GMP documents.
Well versed with technology transfer requirements and implementation.
Ability to review and approve trial and exhibit batches documentation.
Proficiency in document control, including issuance, revision, archival, and controlled document lifecycle management.
Skilled in drafting, reviewing, and ensuring compliance of quality technical documents.
Strong written and verbal communication skills, particularly for interacting with regulatory authorities and internal teams.
Any other relevant duties as assigned by the Management.
Must have "CAN DO" attitude and should be able to work with minimum supervision and maximum responsibility. Must know the people to get the job done.