Job Description

JOB DESCRIPTION:
Primary Job Function:
Coordinate and oversee the labelling process (Label Change Request LCR) across multiples departments including Labelling Team, Supply Chain, internal and external plants and Local Regulatory Affairs.
Ensure compliance with regulatory and quality requirements/standards, manage manufacturing and logistic constraints and implement timely packaging material changes to minimize costs and reduce write-offs.
Core Job Responsibilities:

• Coordinate Labelling Activities for New Product Introduction working in collaboration with Launch Managers to ensure timely product launches
• Ensure on time execution of Label Change Requests (LCR) by aligning regulatory and quality requirements, technical specifications, and implementation dates. Guarantee that LCR implementation does not adversely affect other affiliates sharing the same products or packaging.
• Lead effort to swiftly analyze and resolve bottlenecks in the labelling process, facilitating effective communication and collaboration among stakeholders to ensure smooth and efficient operations.
• Conduct regular performance's reviews with stakeholders to evaluate KPIs, monitor priorities and identify continuous opportunities for continuous improvement in the labeling process.
• Ensure quality and regulatory compliance of labelling activities and processes in accordance with departmental procedures and applicable Abbott policies.
• Manage documentation by creating and maintaining Work Instructions and Standard Operating Procedures related to the labelling process.
• Develop and provide training for Labelling Team personnel and other stakeholders involved in the labelling processes

Supervisory/Management Responsibilities:
Direct Reports: -
Indirect Reports: -
Minimum Education:

• A minimum of bachelor's degree is required, preferably in scientific or business discipline egree or equivalent.

Minimum Experience/Training Required:

• Minimum of 3 years' experience in Life Sciences business (Operations, Regulatory, Quality)
• Proficiency in business systems and tools including Artwork Management System, Enterprise Resources Planning, Project & Portfolio Management solutions.
• Demonstrated expertise and training in GMP/GxP standards for pharmaceutical products

Desired skills/experiences include:

• Business exposure to international markets
• Excellent verbal and written communication skills in English including presentation skills.
• Ability to work effectively within complex organization and collaborate with diverse stakeholders.
• Strong discipline and stress resilience, with proven experience in managing and delivering multiple tasks on time.
• High accuracy and attention to detail, with an understanding of the consequences of poor data quality.
• Strong project management skills, including issue identification, problem analysis and solution development.

The base pay for this position is N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY: Engineering
DIVISION: EPD Established Pharma
LOCATION: India
Mumbai : BKC Building
ADDITIONAL LOCATIONS:
WORK SHIFT: Standard
TRAVEL: Not specified
MEDICAL SURVEILLANCE: Not Applicable
SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)