Macleods Pharma Hiring for PVQA Role

Macleods Pharma Hiring for PVQA Role

17 January, 2022

Role: PV QA Macleods Pharma LTD

Experience: 4 to 8 years.

Job Role: Individual contributor

Job Description:
Incumbent should have exposure Woking in Pharmacovigilance operations or QMS supporting to PVG operations.
Perform audits to ensure compliance with applicable regulatory guidelines and Standard Operating Procedures and Sponsor’s Specific Requirements.
Develop audit plan and conduct audits of studies, processes, systems and facilities to ensure compliance with applicable regulatory guidelines, Standard Operating Procedures .
Support in establishment of Pharmacovigilance (PV) quality management processes in line with Global policies and local regulations.
Support initiatives focused on PV quality, process and compliance improvement.
Plans and conducts Pharmacovigilance system audits in support of global PV activity for post marketed and clinical development products.
Prepare reports and communicate audit findings from audits to auditee.
Follow up all audit reports for completion of corrective actions and ensure timely closure of audit reports.
Plans and conducts system process audits of subsidiaries, vendors, distributors & partners issuing audit reports, suggesting appropriate corrective and preventive action and audit closure
Assisting Pharmacovigilance team to prepare for regulatory inspections.
QMS support to Pharmacovigilance Team

How to Apply: Please send CV to drgirishs@macleodspharma.com

About Company:

Established in 1986, we specialise in the development and manufacturing of APIs and finished dosage pharmaceutical formulations. Our values transcend mere profits and guide us in fulfilling our responsibility towards society.

This quest, for healing the world, drives our performance and helps us move towards our Vision.

Our expertise

We are renowned for our expertise across varied therapies such as antituberculars, antimalarials, antiretrovirals, antibacterials, antidiabetics, antihypertensives and antiasthmatics. We are also known for the largest number of WHO pre-qualified medicines, used in the treatment of HIV/AIDS, Malaria, Tuberculosis (TB) and opportunistic infections.

What we do

We manufacture close to 25 billion units of finished dosages per year. These include tablets, capsules, liquid orals, powders for oral suspension, pressurised metered dose inhalers (pMDI), single dose dry powder inhalers (DPI), dry powders for injections (antiseptic fill) and a variety of topicals like lotions, creams, ointments and gels.

Vision

Our vision is to become a leading global pharmaceutical company by providing high quality, affordable and innovative therapeutic solutions for patients with diverse medical needs.

Mission

To contribute towards improving patients quality of life across the globe, by providing effective and accessible medicines.

1Comments

  • •Hi All,
    Currently Working as Assistant Manager at APCER Life Sciences. Pharmacovigilance section. PFB CORE COMPETENCIES.

    • Argus, ARISg, Emperica trace database experience.

    • Excellent knowledge of medical terminology.

    • In-depth knowledge of MedDRA coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines.

    • Sound evaluative/analytical skills required for reviewing and processing of complex adverse event cases.

    • Actively participated in client audit in Oct 2010 and Apr 2015 and was able to complete it without any critical or major findings.

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