Quality Executive

• Handling documentation related to QA activities such as global SOPs, specifications, and Process Data Sheets.
• Preparation, monitoring, and implementation of SOPs and formats applicable for the TP site.
• Handling complaints, deviations, change control, and CAPA.
• Ensuring timely closure of CAPAs, change control, and deviations.
• Facilitating external, customer, and regulatory audits.
• Conducting training programs for site personnel regarding SOPs and applicable guidelines.
• Reviewing and upgrading site documents/SOPs per regulatory/customer requirements.
• Ensuring approved vendor status and performing vendor evaluations.
• Monitoring and reviewing equipment qualifications and area qualifications (temperature mapping).
• Ensuring timely calibration of temperature monitoring instruments and maintaining the yearly calibration schedule.
• Ensuring trained status of personnel involved in applicable product-related activities.
• Day-to-day monitoring of activities related to process quality.
• Performing site audits concerning GxP.
• Assisting in the development and maintenance of quality systems with clients and DSC Healthcare operations.
• Maintaining and monitoring QA site and client-related activities through timely training on GMP and quality-related processes.
• Supporting operations and QA Management in the preparation and review of relevant procedures and quality documentation.
• Supporting the follow-up and closure of audit issues in a timely manner.
• Supporting client audits and provision of requested information.
• Ensuring DSC meets the requirements in compliance with client standards and Quality Agreements and Indian Regulatory.
• Ensuring site functions such as pest control, preventative maintenance, and cleaning are effectively managed by Site management and escalating issues where necessary.
• Supporting the calibration and validation schedule.

Experience:
2 to 3 years in the pharmaceutical or medical device warehousing industry, preferably in Quality Assurance.

Qualification: B.Sc. / B. Pharm, Science graduate.

Skills and Competencies:

• Technical skills in quality assurance and regulatory compliance.
• Strong documentation and training skills.
• Ability to facilitate audits and manage vendor evaluations.
• Knowledge of GxP, GMP, and GDP guidelines.
• Strong organizational and monitoring skills.
• Effective communication and interpersonal skills.
• Attention to detail and problem-solving abilities.