Assistant Manager Production - Pharma

Abbott; New Delhi; On-site; INR 800,000 - 1,000,000; Full time

Job summary

Abbott in India seeks a qualified professional to oversee cGMP production compliance and equipment qualification. The role includes managing SOPs, CAPA, audits, and cross-functional coordination to ensure regulatory standards are met.

The incumbent will train staff, manage inventory, and coordinate with QA/QC, engineering, and production teams to sustain quality and efficiency on the shop floor.

Qualifications

• Experience with cGMP and regulatory standards.
• Regulatory documentation and SOP management.
• CAPA implementation and compliance auditing.

Responsibilities

• Compliance to cGMP standards across production.
• Qualification of production equipment: carrying, reviewing, approval.
• Ensure compliance with specifications and validated methods.
• Train staff for qualification and operation of equipment.
• Prepare and review SOPs for equipment and procedures.
• Manage consumables requisitions and inventory within budget.
• Implement Quality Management Systems per cGMP and international standards.
• Lead CAPA for non-conformances and self-inspection findings.
• Control environmental conditions affecting product quality.
• Coordinate calibration/maintenance of production equipment with engineering/QA/QC.
• Document routines per regulatory requirements.
• Maintain cleanliness of production areas and equipment per SOPs.
• Coordinate with PPIC, QC, QA, PLM, and others for production activities.
• Organize job responsibilities across technicians and staff; manage absenteeism.
• Verify dispensed input materials against process orders.
• Monitor in-process controls and production output daily.
• Update BPR/BMR online and ensure SAP entries.
• Review production records before QA submission.
• Review related production documentation.
• Monitor manpower utilization, yield, waste, and Opex.
• Ensure audit readiness and regulatory compliance.
• Handle online systems and software (SolTRAQs, ISOtrain, Darius, Brainshark, Harmony).
• Ensure SAP BOM updates, new item codes, batch transactions.

Job description

Job Description Followings will be the Coe Job responsibilities of the position holder:

• Compliance to laid standards of current Good Manufacturing Practices (cGMP).
• Carrying, review and approval of qualification of production equipment.
• Ensure compliance with specifications and validated methods.
• Training and evaluation of the Management and Non-Management staff for the qualification to specific task or to operate specific equipment.
• Preparation and review SOPs for related equipment’s and procedures.
• Raising, review of requisition for the requirement of consumables items and check on its inventories according to their approved budget.
• Implementation of Quality Management Systems as per cGMP and international standards.
• Implementation of Corrective and Preventive Actions (CAPA) for non-conformances and self-inspection findings.
• To exercise effective control over environmental conditions in manufacturing and other related activities, which may adversely affect the product quality.
• To Coordinate and approve calibration/maintenance of all production equipment’s and instruments with engineering / QA / QC and outside agencies.
• To carry out routine documentation per regulatory requirements.
• Adhere to specified working hours.
• To ensure and maintain cleanliness of production areas and equipment as per SOPs.
• Coordinate with production, PPIC, QC, CQA, PLM, QA and others for smooth production activities.
• Organize the job responsibilities to the technicians, officers, executives, assistant managers as per plan and to manage absenteeism.
• Verification of dispensed input materials against process orders.
• Continuous monitoring of in-process controls in all production areas.
• Continuous monitoring and improving production output on daily basis.
• To fill, maintain and approve BPR/BMR online and to ensure online SAP entries.
• To evaluate and sign production records before QA submission.
• To review production and related documentation.
• To Monitor and control of manpower utilization, yield, waste, and Opex.
• To Ensure audit readiness and regulatory compliance.
• Handling of online systems and software and ensure review and approval in systems like SolTRAQs, ISOtrain, Darius, Brainshark, Harmony etc.
• Ensure the compliance of SAP activities related to updation of BOM, creation of new item codes, batch transactions etc.
• Ensure compliance with BBS and BBQ.
• To conduct self-inspection/internal audits as per site Internal Audit Program.
• To Investigate and provide CAPA for audit observations (internal and external).
• To conduct cGMP and GDP training in LVP facility.
• In absence of the position holder, the sub-ordinate / assistant Manager working in the section, or the authorized designee (as applicable) shall be responsible for day to day working.