Executive, Quality Assurance Operations

Job Summary

• IPQA activities.
• Warehouse QA activities
• MMaR S / MPaRs Review.

Job Responsibilities

• Line clearance of Various in process stage such as Dispensing Granulation Compression Coating Packaging and Sampling.
• Routine monitoring of all functional area to ensure adherence to the SOPs.
• Co-ordination & Ensuring timely execution of Sampling activity of Raw and Packing materials.
• Co-ordination of daily activities in Manufacturing and packaging areas.
• 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.
• Co-ordination & ensuring timely execution of in-process activities for manufacturing and Packaging.
• Coordination for implementation of CAPA.
• In-process checks during manufacturing & packaging stage Performance of AQL collection of samples as applicable and trending of AQL.
• Sampling of validation & commercial batch Shelf life expiration date (SLED) Bulk completion date (BCD) sampling Hold time study sample In-process samples/Finished product samples Collection storage and disposal of Reserve Sample.
• Preparation Review and updating of standard operating procedure.
• Planning co-ordination and sampling of Raw and Packaging materials.
• Co-ordination for Process validation & cleaning validation execution.
• Approved/ Rejected labels affixing for API Excipients Primary and Secondary packaging materials.
• Swab/Rinse sampling for the cleaning verification & validation programme cleaning & verification of sampling thiefs & accessories.
• Co-ordination for in-house and external calibration.
• Review of Master Manufacturing Records & Master Packing records & logbooks.
• Works as a member of a team to achieve all outcomes.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Preparation for regulatory audits and making the compliance for the same.
• To ensure that the impact of any risk reduction measures is not detrimental to the systems facilities utilities equipment or processes.
• 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
  • 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
• Experience:
  • Minimum 02 Years of experience in GMP Regulated Pharmaceutical industry.