Sr. Officer- Quality Compliance

Job Description

Title: Sr. Officer- Quality Compliance

Company Name: Sun Pharmaceuticals (EZ) Limited

Vacancy: Not specific

Job Location: Narayanganj, Gazipur (Gazipur Sadar)

Employment Status: Full-time

Educational Requirements:
∎ Master of Science (MSc) in Chemistry , Applied Chemistry Biochemistry,, Master of Pharmacy (M.Pharm)
∎ Skills Required: Computer Operator related Skill is required, CSV, Excellent communication skill, Familiar with SAP ERP system, Internal Audit, Learning and Development, Quality Management

Experience Requirements:
∎ 5 to 6 year(s)
∎ The applicants should have experience in the following area(s): QUALITY ASSURANCE, Quality compliance
∎ The applicants should have experience in the following business area(s): Pharmaceuticals

Job Responsibilities:
∎ Ensure completion of all Regulatory and Customer inspection observation response, update & commitments.
∎ Ensure completion of all CQA inspection observation response, update & commitments.
∎ Monthly Review and analyze the progress of compliance action plan derived against gap identified for observations from Sun sites(CQA audit and external regulatory observations (MoH, CDSCO, 483, WL)).
∎ Global Action Assessment & implementation with timely closure of Site CAPAs.
∎ Completion of site risk assessment Manage all action items and ensure completion of actions from Site Risk Assessment activity within timeline.
∎ Lead and drive special project for process, procedure & system improvement at site. Simplification of Site Processes and Procedures at site.
∎ Timely Implementation of plan and timely compliance of Gemba Walk Observations.
∎ Improve Process and System with identification of area for Potential DI cases and where ALCOA principles are not followed along with remediation plan.
∎ To review site SOP for gap assessment with site functions, find compliance and recommended for it’s approval and its effectiveness monitoring.
∎ To coordinate site training activities ( LMS & ILT) and it’s tracking , trending and communicate with concern HODs and find compliance along with it’s effectiveness monitoring.
∎ To coordinate site self-inspection program( internal audit) and it’s tracking , trending and communicate with concern HODs and find compliance along with it’s effectiveness monitoring.

Additional Requirements:
∎ Age 26 to 30 years
∎ Having 5-6 years experience in the similar positions in a reputed pharmaceutical company
∎ Good analytical skills
∎ Self-management including: Ability to prioritize own work load, able to work independently, committed to meet deadlines and maintain confidentiality in all areas of work.

Salary: Negotiable

Compensation & Other Benefits:
∎ Tour allowance, Medical allowance, Provident fund, Insurance, Gratuity
∎ Lunch Facilities: Partially Subsidize
∎ Salary Review: Yearly
∎ Festival Bonus: 2
∎ LTA (Additional Bonus)

Job Source: Bdjobs.com Online Job Posting.

Application Deadline: 23 May 2023

Company Information:
∎ 14 May 2023
∎ Sun Pharmaceuticals (EZ) Limited

Category: Medical/Pharma

: