Title: QA Officer
Company Name: M/s Super Power Pharmaceuticals Ltd.
Vacancy: 04
Age: Na
Job Location: Narsingdi (Belabo)
Salary: Negotiable
Experience:
Bachelor of Pharmacy (B. Pharm) / Master of Pharmacy (M. Pharm)
Candidate must have computer skill & well conversant with Microsoft Office applications.
Candidate should have registration number given by Bangladesh Pharmacy Council.
Candidate should have profound knowledge on Standard Operating Procedure (SOP), Pharmaceutical Analysis, Pharmaceutical Calibration/Validation, Process Validation, Proper Documentations, Regulatory Affairs etc. Candidate should be skilled on HPLC, FTIR, UV, ASS, GC, TLC & others QC Equipment’s. Enable to prepare MOA, COA, Method Verifications and Specifications, Method Validations. Coordinate pharmaceutical-related activities for all products.
Documentation & SOP Management: Drafting, reviewing, and updating Standard Operating Procedures (SOPs) and batch manufacturing records (BMRs) to ensure repeatable and compliant processes.
Quality Management Systems (QMS): Handling critical compliance workflows, including:
Change Control: Managing modifications to equipment or processes.
Deviations: Investigating unexpected outcomes using root cause analysis.
CAPA: Implementing Corrective and Preventive Actions to prevent recurrence of issues.
Auditing: Conducting regular internal audits and assisting with external regulatory or supplier inspections to maintain "audit-ready" status.
Batch Review & Release: Reviewing all production data and testing records to ensure a batch meets all specifications before it is released to the market.
Validation Oversight: Coordinating and reviewing Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) for equipment and manufacturing processes.
In-Process Quality Assurance (IPQA): Performing real-time line clearances, monitoring shop floor activities, and ensuring environmental compliance during manufacturing.
Training: Designing and conducting GMP training for personnel to ensure competency across the organization.
Technical Knowledge: Deep understanding of GxP (GMP, GDP, GLP) and international regulatory frameworks like ICH Q10.
Communication: Strong written and verbal skills for documenting findings and collaborating with cross-functional teams (Production, QC, Engineering).
Salary & other benefits will be considered as per company rules & policies.
Special preference will be given to the candidates who have practical knowledge & experience in launching injectable/Sterile Products and attractive salary will be offered to such candidates.