Assistant Manager, Quality Control

Job Description

Title: Assistant Manager, Quality Control

Company Name: A reputed Pharmaceuticals Company

Vacancy: 01

Age: at least 30 years

Location: Mymensingh (Bhaluka)

Salary: Negotiable

Experience:
∎ 4 to 5 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies

Published: 8 Jan 2025

Education:
∎ Master of Pharmacy (M.Pharm)

Requirements:

Additional Requirements:
∎ Age at least 30 years
∎ Excellent communication and interpersonal skills.
∎ Leadership experience with the ability to motivate and develop a high-performing team.
∎ Detail-oriented with strong analytical and problem-solving skills.
∎ Excellent communication and interpersonal skills.
∎ Leadership experience with the ability to motivate and develop a high-performing team.
∎ Detail-oriented with strong analytical and problem-solving skills.

Responsibilities & Context:
∎ 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.
∎ 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.

Skills & Expertise:

Compensation & Other Benefits:
∎ Mobile bill, Weekly 2 holidays
∎ Lunch Facilities: Full Subsidize
∎ Salary Review: Yearly
∎ Festival Bonus: 2
∎ Single accommodation in the factory premises

Workplace:
∎ Work at office

Employment Status: Full Time

Gender:
∎ Only Male

Job Location: Mymensingh (Bhaluka)

Company Information:
∎ A reputed Pharmaceuticals Company

Read Before Apply: Please apply only who are fulfilling all the requirements of this job

Application Deadline: 2 Feb 2025

Category: Others