Nidhi NK, QA Specialist

Nidhi NK

QA Specialist

City Pharmacy Company

Lieu
Émirats Arabes Unis - Sharjah
Éducation
Master, Pharmacy
Expérience
7 years, 2 Mois

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Expériences professionnelles

Total des années d'expérience :7 years, 2 Mois

QA Specialist à City Pharmacy Company
  • Émirats Arabes Unis - Sharjah
  • avril 2018 à septembre 2021

functions throughout the supply
chain in City Pharmacy to ensure highly disciplined compliance
with all the products, process quality parameters and standards.
• To coordinate with relevant departments for setup, enforcement
and management of Quality Management System & Environment
Management System and Business Continuity Management
system to in line with ISO accreditation and its compliance with
principal companies and local regulation requirements.
• To generate documents and information that allow operational
team to effectively manage the business from Quality
perspective and archival of relevant documents
• To monitor the items to ensure compliance with shelf life to
adhere FEFO Protocols
• To prepare the In-house training plans and to ensure initial and
continuous training programs are implemented and maintained
• Handling of Product Quality Complaints through network and its
management and reporting to QA Manager.
• Monitoring of Warehouse temperature and Humidity through
DicksonOne Monitoring system and Fleet temperature through
VZone GPS Monitoring system and guiding the Warehouse team
for maintaining the required temperature to minimize the
discrepancies and also to maintain the temperature for time
sensitive products
• To develop and maintain all the relevant documents in the
course of compliance for principal company’s and local
regulatory requirements.
• To liaise during audits from Principal Companies, Accreditation
bodies, local authorities’ audits & follow up with the different
department heads for effective implementation of corrective and

Senior Executive à Syngene Clinical
  • Inde
  • mars 2015 à octobre 2017

ISO 22301:2012 Control
Procedures
HSQE Assurance Audits
preventive actions as well as to conduct Internal Audit as per
Quality Management System and follow up on CAPA against
audit findings
• To prepare the Process Deviation, if any deviation occurs from
the mentioned process
• Responsible for performing QA checks for return goods and also
to segregate any medical supplies unfit for distribution
• To coordinate and promptly perform any Recall operations
• To ensure that Suppliers and Customers are approved
• To monitor and analyze the Inventory Management of health
care products
• To perform audit and approve any subcontracted activities
which may impact on GDP
• To prepare the BCP Testing Plan and to follow-up for execution
of BCP Testing at City pharmacy (All Divisions)
• In case of business disruption to perform the department tasks
as per City Pharmacy business & disaster recovery plan assigned
by CPC Management
• To perform In-Process Quality checks in the absence of Quality
Officer to check the application and implementation of QMS and
GDP at work place.

Trainee à Clinigene International Limited
  • Inde
  • mars 2014 à février 2015

Éducation

Master, Pharmacy
  • à Jawaharlal Nehru University
  • août 2014

Pharmaceutical Analysis & Quality Assurance, Jawaharlal Nehru Technological University CMR College of Pharmacy - Hyderabad |

Baccalauréat, Pharmacy
  • à Jawaharlal Nehru Technological University Sai Pranavi College of Pharmacy
  • janvier 2012

,

Specialties & Skills

21 CFR PART 11
PROTOCOLS
QUALITY
QUALITY CONTROL
VALIDATION
NETWORKING
REPORTS

Langues

Anglais
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Hindi
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