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Executive, QA Operations

Executive, QA Operations

APOTEXBengaluru, Karnataka, India
16 hours ago
Job description

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable innovative medicines and health products for millions of people worldwide with a broad portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto with regional offices globally including in the United States Mexico and India we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit : .

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.

    At Apotex we are committed to fostering a welcoming and accessible work environment where all everyone feels valued respected and supported to succeed.

    We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing please advise us if you require an accommodation.

    Key Skills

    Corrosion Inspection,Evaluation,Drafting,Activex,HR Operations

    Employment Type : Full Time

    Experience : years

    Vacancy : 1

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    Operation Executive • Bengaluru, Karnataka, India

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