Manager- Quality Assurance

Africure Pharmaceuticals Limited; Palghar; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Africure Pharmaceuticals Limited is seeking a QA/QMS leader for its plant in India. The role focuses on managing Quality Management Systems, SOPs, and regulatory compliance to ensure product quality and audit readiness.

The candidate should hold B. Pharma / M. Pharma with 7–10 years in a similar OSD function, and possess fluent English communication skills. MBA is an added advantage. This is an on-site role aimed at maintaining cGMP standards.

Qualifications

• Bachelor or Master in Pharma (B.Pharm/M.Pharm) mandatory.
• MBA qualification will be an added advantage.
• Fluent in written and spoken English.
• 7 to 10 years in a similar function in OSD.

Responsibilities

• Responsible and Accountable for all Quality Management Systems at the Plant.
• SOP management and implementation of corporate quality guidelines.
• Ensure documentation is updated daily and regulatory and statutory requirements are complied with.
• Ensure optimum usage of manpower resources and train them to deliver.
• Ensure products manufactured meet Pharmacopeia standards with zero defects and zero recalls.
• Periodic audits and self-inspection to maintain cGMP and 100% audit readiness.
• Handle Batch release, OOS and product complaints/recalls.
• Generate relevant and accurate MIS.

Skills

Quality Management

SOP implementation

Regulatory compliance

Education

B. Pharma / M. Pharma

MBA advantageous

Tools

MIS reporting

cGMP knowledge

Job description

Role & responsibilities

1. Responsible and Accountable for all Quality Management Systems

at the Plant.

2.SOP management and implementation of the Corporate quality

guidelines.

3.Ensure that all documentation is updated daily, and all regulatory

and statutory requirements are complied with.

4.Ensure optimum usage of all manpower resources and train and

develop them to achieve their deliverables.

5.Ensure that the products manufactured are to the exacting

standards of the Pharmacopeia with zero defects and zero

product recalls.

6.Periodic Audits and self-inspection to ensure that all the

requirements of cGMP are maintained and that the plant is always

100% audit ready.

7.Responsible for handling operational matters such as Batch

release, OOS and product complaints/Recalls.

8.Generate relevant and accurate MIS.

Preferred candidate profile

B. Pharm / M. Pharma

MBA qualification will be an added advantage and must be fluent in Written and Spoken English.

Minimum 7 to 10 years in a similar function in OSD