What are the responsibilities and job description for the Packaging Specialist position at Piramal Pharma Ltd?
Job Description
Essential Duties and Responsibilities
Key Competencies (knowledge, skills and abilities every person must possess to be successful)
Essential Duties and Responsibilities
- Support packaging operations through execution of projects related to process optimization, validation, and equipment qualification.
- Prepare, review, and maintain GMP documents, including SOPs, batch records, protocols, and reports, ensuring accuracy and compliance with regulatory and site standards.
- Assist in the management, investigation, and documentation of customer complaints, deviations, and CAPAs to ensure timely closure and preventive action implementation.
- Participate in root cause analyses, risk assessments, and continuous improvement initiatives (e.g., Kaizen, Lean, Six Sigma projects) to enhance process performance and product quality.
- Support packaging validation and qualification activities, including documentation and data collection.
- Monitor compliance within the packaging area to ensure readiness for regulatory inspections and internal audits at all times.
- Assist in maintaining oversight of change controls, ensuring proper documentation and impact assessment for packaging processes.
- Support the implementation of process improvements to enhance Packaging OEE (Overall Equipment Effectiveness) and reduce waste.
- Collaborate with cross-functional teams to troubleshoot packaging issues and implement sustainable solutions.
- Provide regular project updates, including progress tracking, risks, and mitigation strategies, to management and stakeholders.
- Ensure proper control, storage, and archival of packaging-related documentation per data integrity and document retention policies.
- Support internal and external audit activities through document preparation, participation, and follow-up actions.
- Promote a culture of quality, safety, and continuous improvement within the packaging operations.
Key Competencies (knowledge, skills and abilities every person must possess to be successful)
- Strong understanding of cGMP, GDP, and pharmaceutical quality system requirements.
- Excellent analytical and problem-solving skills with the ability to interpret data and identify improvement opportunities.
- Knowledge of Lean, Six Sigma, and continuous improvement methodologies (Green Belt certification preferred).
- Detail-oriented with excellent organizational and documentation management skills.
- Strong communication and interpersonal skills; able to interact effectively with cross-functional teams and external stakeholders.
- Proactive, adaptable, and able to manage multiple priorities in a fast-paced, regulated environment.
- Professional demeanor with a commitment to maintaining confidentiality and ethical standards.
- Skilled in critical thinking, with the ability to evaluate alternative solutions and propose effective corrective actions.