Manufacturing Specialist
- Job Role: Manufacturing Specialist - 1st Shift
- Job Locations: Fall River
- Required Experience: 5 - undefined Years
- Assist in the coordination of daily packaging activities to meet production schedules of projects.
- Monitor packaging processes for adherence to cGMP, FDA, and Cipla's quality standards.
- Identify and resolve operational inefficiencies, escalating complex issues when necessary.
- Ensure proper documentation of batch records, logs, and deviations.
- Monitor production schedules to ensure timely execution and minimize delays to support ongoing projects.
- Assist in investigating deviations, non-conformances, and CAPAs (Corrective and Preventive Actions).
- Work closely with Quality Assurance (QA) to ensure adherence to standard operating procedures (SOPs).
- Assist in coordinating materials, equipment, and workforce allocation for optimal resource utilization.
- Identify areas for operational improvements, focusing on reducing waste and enhancing efficiency.
- Assist in implementing new technologies and automation in production workflows.
- Collaborate with Team, Quality, Supply Chain, Project Management, Engineering, and R&D teams to resolve operational bottlenecks
- Support training efforts by ensuring clear communication of standard operating procedures (SOPs)
- Monitor operational metrics such as efficiency, compliance rates, and resource utilization.
- Identify areas for improvement in packaging activities and contribute to process enhancements.
- Support initiatives aimed at improving overall productivity through data analysis and performance reviews.
- Develop and maintain strong professional relationships with suppliers/vendors to ensure compliance with quality standards and timely delivery of goods and services.
- Create and manage purchase requisition (PR) using SAP for services, contracts, equipment, consumables, and miscellaneous items, ensuring accuracy & alignment with end-user requirements.
- Maintain clear and effective communication with internal and external stakeholders to address issues, facilitate smooth operations, and ensure alignment with project strategies.
- Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Packaging Practices (cGMP).
- Participate in safety related programs and or safety teams as needed.
- Enforce and follow safety regulations and ensure that their working area is clean.
- Adhere to CIPLA’s Safety, Health, and Environmental policies.
- Other duties assigned as required by Reporting management / Dept. Head.
- Bachelor’s degree in pharmaceutical sciences/ electrical/ mechanical / production or related fields of study.
5-11 years of experience in packaging, operations, team management. Preference will be given to candidates with experience in pharmaceutical MDI packaging. Skills/ Competencies
- Understanding of cGMP, FDA regulations, and pharmaceutical packaging processes.
- Experience in SAP system and packaging data analysis tools.
- Strong problem-solving abilities, attention to detail, and ability to work in a fast-paced, regulated environment.
- Excellent communication skills, drive, and sense of urgency
- Excellent computer skills, specifically Microsoft Office Suited.
- Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Packaging Practices (cGMP), complying with legal regulations, monitoring the environment.
- Knowledge of pharmaceutical packaging and related documents.
- Knowledge and experience writing, revising, and creating cGMP records and SOP’s.
- Experience with quality system compliance.
- Ability to work effectively both independently and as part of a team.
- Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
- Experience in Inhalation products (Metered Dose Inhaler) is a plus.
- Stand or walk for extended periods of time.
- Reach with hands and arms.
- Use fingers to handle or feel.
- Ability to lift up to 50lb when required.
- Safety/Personal Protective Equipment (PPE) required for this job.
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