Executive - QA(Apotex)

Roles and Responsibilities

Job Summary

• IPQA activities.

• Warehouse QA activities

• MMaR’ S / MPaR’s 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 thief’s & 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.