Job opportunity for experienced professionals in QA department at Emcure-Apply before 25th May 2024


Website Emcure

About Emcure

Emcure Pharmaceuticals is an Indian multinational pharmaceutical company headquartered in Pune, Maharashtra, India. Established in 1981 by Satish Mehta, Emcure has grown into one of India’s leading pharmaceutical companies, with a significant presence in over 70 countries globally. The company focuses on a wide range of therapeutic areas, including cardiology, nephrology, oncology, anti-infectives, and critical care. Emcure is known for its research and development capabilities and its diverse portfolio of high-quality generic drugs, branded generics, and specialty products. It has manufacturing facilities compliant with international regulatory standards, enabling it to produce a wide range of pharmaceutical formulations.

Emcure Looking for Experienced Professionals in QA Department for Our Injectable Unit, Sanand (Ahmedabad)

Post: AGM / DGM

Job Description:

  • Detailed Knowledge: Candidates should possess detailed knowledge and extensive experience in injectable manufacturing processes, including Aseptic and Terminal processes.
  • Regulatory Compliance: Proficiency in compendia and regulatory requirements for aseptic processing, contamination control strategy programs, and related controls.
  • Expertise in Qualification: Demonstrated expertise in facility, utility, and equipment qualification, along with relevant guidance.
  • Software Proficiency: Knowledge of software systems for Quality Management Systems (QMS), Document Management Systems (DMS), and Laboratory Information Management Systems (LIMS).
  • Compliance Assurance: Ensure compliance with QMS activities such as Deviations, Change Control, CAPA, Market Complaints, and Recall, ensuring timely closure.
  • Leadership Role: Lead the Quality Assurance department across GXP functional areas (GMP, GLP, GCP, document control, and training).
  • Regulatory Liaison: Handle regulatory inspections and customer audits, ensuring compliance and implementing Corrective and Preventive Actions (CAPA).
  • Risk Management: Conduct Quality Risk Management and monitor the effectiveness of mitigation plans to reduce risks.
  • Validation Oversight: Plan, monitor, and ensure Process & Cleaning Validation/Verification.
  • Batch Record Review: Review and approve executed batch records for drug products and labeled products.
  • Procedure Review: Review procedures across Warehouse, Production, Engineering, QA, and QC to meet cGMP requirements.
  • Regulatory Experience: Experience in facing regulatory inspections from USFDA and EU is essential.

Expected Skills:

  • Strong managerial and administrative skills, capable of supporting the section head effectively.

Additional Information:

  • Qualification: M.Pharm./ B.Pharm./ M.Sc.
  • Experience: 16 to 22 years
  • Location: Sanand (Ahmedabad)
  • Industry Type: Pharma/ Healthcare/ Clinical Research
  • Functional Area: QA Department
  • End Date: 25th May 2024

Interested candidates may share their updated CV on with the subject line “QA_Lead”.

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