Asst. Manager/Manager (QA), Sterile

Job Description

Title: Asst. Manager/Manager (QA), Sterile

Company Name: Ad-din Pharmaceuticals Ltd.

Vacancy: --

Location: Jashore

Salary: Negotiable

Experience:
∎ At least 5 years

Published: 19 Nov 2024

Education:
∎ M.Pharm/B.Pharm from any reputed university with sound academic records
∎ M.Pharm/B.Pharm from any reputed university with sound academic records

Requirements:

Additional Requirements:
∎ Having minimum 5-years working experience in any pharmaceuticals company in sterial area
∎ Must be hard worker, self-motivated, honest, sincere & obedient
∎ Must have experience in computer knowledge (Microsoft office, internet & email)
∎ Having minimum 5-years working experience in any pharmaceuticals company in sterial area
∎ Must be hard worker, self-motivated, honest, sincere & obedient
∎ Must have experience in computer knowledge (Microsoft office, internet & email)

Responsibilities & Context:
∎ Lead the development, implementation, and maintenance of the Quality Management System (QMS) for the new sterile injectable and ophthalmic plant
∎ Ensure compliance with Current Good Manufacturing Practices (cGMP), regulatory guidelines, and international standards during the establishment and operation of the plant
∎ Oversee the validation and qualification of sterile production processes, equipment, and facilities
∎ Coordinate and conduct internal audits, risk assessments, and root cause analyses to ensure continuous improvement in quality systems
∎ Lead investigations of deviations, CAPAs & quality incidents & provide solutions to mitigate risks
∎ Collaborate with regulatory bodies and internal teams to prepare for successful regulatory inspections and approvals
∎ Ensure accurate and timely documentation of all activities related to the new sterile plant project
∎ Identify and resolve technical and operational issues to ensure smooth project execution
∎ Lead the development, implementation, and maintenance of the Quality Management System (QMS) for the new sterile injectable and ophthalmic plant
∎ Ensure compliance with Current Good Manufacturing Practices (cGMP), regulatory guidelines, and international standards during the establishment and operation of the plant
∎ Oversee the validation and qualification of sterile production processes, equipment, and facilities
∎ Coordinate and conduct internal audits, risk assessments, and root cause analyses to ensure continuous improvement in quality systems
∎ Lead investigations of deviations, CAPAs & quality incidents & provide solutions to mitigate risks
∎ Collaborate with regulatory bodies and internal teams to prepare for successful regulatory inspections and approvals
∎ Ensure accurate and timely documentation of all activities related to the new sterile plant project
∎ Identify and resolve technical and operational issues to ensure smooth project execution

Compensation & Other Benefits:
∎ Provident Fund, Gratuity, Festival Bonuses. Health Service benefits as per company policy.
∎ Provident Fund, Gratuity, Festival Bonuses. Health Service benefits as per company policy.

Employment Status: Full Time

Job Location: Jashore

Read Before Apply:

Interested candidates fulfilling the above-mentioned criteria are requested to apply through [email protected]

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