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

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 mayur.desai@emcure.com with the subject line “QA_Lead”.

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