Assistant Manager/ Sr. Executive - Quality Assurance (Pharmaceuticals)

Job Description

Title: Assistant Manager/ Sr. Executive - Quality Assurance (Pharmaceuticals)

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

Vacancy: Not specific

Job Location: Gazipur

Employment Status: Full-time

Educational Requirements:
∎ B. Pharm/ M. Pharm/ M.Sc. in Biochemistry/Chemistry/Applied Chemistry from any renowned University.

Experience Requirements:
∎ 5 to 9 year(s)

Job Responsibilities:
∎ Thorough Knowledge on GxP and Quality Management System.
∎ Preparation and review of site master documents such as Quality Manual, Site Master File, Validation Master Plan, Protocols, SOPs, EOPs, ECPs, BMRs, BPRs, Methods,Specifications, Calibration/validation etc.
∎ Experience on production operations of Solid dosage Forms, Dry Powder for Suspension, Soft Gelatin Capsule,Oral Liquid, Cream, Ointment and Suppository, Eye Drops, Vail & Ampoule filling, Metered Dose & Dry Powder Inhaler Products. Batch documents review, bulk product release on time for next step, compilation and batch release.
∎ Supervise IPQA (In Process Quality Assurance) activities and the team. Allocation of manpower to complete the IPQA activities and strengthen the IPQA team for compliance.
∎ Experience on handling of investigation of Customer complaint, Deviation/QIR, Out of Specification, Out of Trend, Rejection, Return and Recall.
∎ Root cause analysis, CAPA implementation and follow up.
∎ Handle Quality Risk Management and ability to analyze and resolve problems.
∎ Handling of Change control and implementation of change(s) effectively.
∎ Review of APQR (Annual Product Quality Report) and data analysis. Conduct, reporting and follow up of internal audit/ self-inspection and overseas/local vendor audit.
∎ Ensure execution of calibration, qualification and validation are performed as per plan for GMP compliance.
∎ Experience as an expert to face local and other regulatory international audits.
∎ Train up junior/new colleagues/employees on departmental SOPs/activities and other GMP modules.
∎ Ensure data integrity all over the plant.
∎ Ensure good documentation practice all over the plant.
∎ Ensure timely archiving of documents and destruction of expired documents for the control of quality documents.
∎ Monitoring of Quality Control, Microbiology, warehouse and engineering activities to meet the regulatory requirements.
∎ Ensure implementation of health, safety and environmental requirements all over the plant for regulatory compliance.
∎ Adheres to cGMP guidelines for the continuous improvement of quality management system.

Additional Requirements:
∎ Work experience both in sterile and non-sterile facilities.
∎ Ability to take challenges to establish the quality system.
∎ Experience on SAP / ERP system and other spreadsheet software data analysis.
∎ Strong personal & professional ethical values are essential.
∎ Candidates must possess excellent communication & interpersonal skills and Leadership Quality to lead the team successfully and achieve organisational goal.

Salary:
∎ We offer excellent work environment, attractive compensation package and performance based career progression as per company policy.

Application Deadline: July 29, 2019

Company Information:
∎ 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