Senior Executive, Quality Assurance Operations

Job Summary

• Sampling activity.
• IPQA activities.
• CCR initiation, QA assessment in QMS Track wise.
• SME for Raw material sampling Packing material sampling, Liquid sampler and Tuscan operation.

Job Responsibilities

• Co-ordination & Ensuring timely execution of Sampling activity of Raw and Packing materials.
• Preparation, Review and updating of standard operating procedure.
• To ensure line clearance for dispensing, sampling and packing activity.
• Routine monitoring of all functional area to ensure adherence to the SOPs.
• Create signature and methods for raw materials by using Truscan RM analyzer.
• Approved / Rejected labels affixing for API, Excipients, Primary packing and secondary packing materials finished goods and operation supplies.
• Verification of Temperature and Relative Humidity reports generated from TESTO software.
• To perform the QMS (change control) activities as per access approvals.
• To perform necessary SAP transaction as per access approvals.
• Review and co-ordination for in-house and external calibration.
• Imparting training & co-ordination for implementation of training activities.
• In-process checks during packing.
• Sampling of Finished products.
• To ensure training completion as required.
• Review of executed batch packing records & logbooks.
• Issuance and verification of packing batch documents.
• Collection of swab sample as applicable.
• Co-ordination for Process validation / cleaning validation.
• Co-ordination for Qualification activities as applicable.
• Preparation for regulatory audits and making the compliance for the same.
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• All other duties as assigned.

Job Requirements

• Education:
  • Minimum Bachelor of Pharmacy/ Science or any equivalent degree.
• Knowledge, Skills and Abilities
  • Should possess good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet.
  • Preparation and review of SOP.
• Experience
  • Minimum 6 years’ experience in GMP Regulated Pharmaceutical industry.
  • 4 to 6 years