Senior Manager Production

Thornton Tomasetti; India; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Abbott in India is seeking applicants for a manufacturing QA/compliance role. The position emphasizes adherence to cGMP standards, qualification reviews for production equipment, and CAPA implementation to address non-conformances and internal audit findings.

The role will involve training staff, maintaining regulatory documentation, and coordinating with multiple departments to ensure audit readiness and quality compliance across production areas.

Qualifications

• Experience implementing cGMP in manufacturing.
• Experience approving equipment qualifications.
• Knowledge of SAP and validated methods.

Responsibilities

• Ensure compliance with cGMP and international standards.
• Carry out qualification reviews and approvals for production equipment.
• Train and evaluate staff for task-specific qualifications.
• Prepare and review SOPs for related equipment and procedures.
• Coordinate calibration/maintenance of production equipment with engineering/QA/QC.

Skills

cGMP

Regulatory compliance

CAPA

SOPs

Documentation

Tools

SAP

SolTRAQs

ISOtrain

Darius

Brainshark

Harmony

Job description

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. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Manufacturing DIVISION: EPD Established Pharma LOCATION: India > Village Mauza : Baddi ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Keyboard use (greater or equal to 50% of the workday)

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.