Job Description

Title: Senior Executive/ Assistant Manager - QA

Company Name: SUNMAN-BIRDEM Pharma Ltd.

Vacancy: Not specific

Job Location: Mymensingh (Bhaluka)

Employment Status: Full-time

Educational Requirements:
∎ Master of Pharmacy (M.Pharm), Bachelor of Pharmacy (B.Pharm)
∎ Skills Required: QUALITY ASSURANCE

Experience Requirements:
∎ 3 to 7 year(s)
∎ The applicants should have experience in the following area(s): PHARMACUTICALS, QUALITY ASSURANCE
∎ The applicants should have experience in the following business area(s): Pharmaceuticals

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.
∎ Lead a team of professionals in Quality assurance Department and Carry out responsibilities in accordance with the organization's policies, procedures, and FDA, ICH, cGMP, Regulatory rules, regulations and guidelines.
∎ Reviewing and assessment the whole batch along with all QC analysis documents for each batch of product for giving final release.
∎ Other Tasks assigned by the Managements in different business situations.

Additional Requirements:
∎ Both males and females are allowed to apply
∎ The candidate must have experiences in Pharmaceuticals Quality Assurance

Salary: Negotiable

Compensation & Other Benefits:
∎ Mobile bill, Weekly 2 holidays
∎ Lunch Facilities: Full Subsidize
∎ Salary Review: Yearly
∎ Festival Bonus: 2
∎ As per company policy

Job Source: Bdjobs.com Online Job Posting.

Application Deadline: 20 Jul 2021

Company Information:
∎ 20 Jun 2021
∎ SUNMAN-BIRDEM Pharma Ltd.
∎ Address : 15/1 - 15/4, Tropical Mollah Tower, Level -12, Middle Badda, Dhaka -1212
∎ Web : www.sunmanbirdem.com
∎ Business : Pharmaceuticals product manufacturing, Marketing, Sales and Distributions

Category: Medical/Pharma

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Source: bdjobs.com

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