Quality Control Assurance
Resume:
Sunita Sharma
************@*****.***
Delhi, India
https://www.linkedin.com/in/sunita-sharma-1974-june-29th/
Academic Qualifications
Course Institute/School Passing Year
B.Sc. Biochemistry (Hons.) Delhi University 1994
Senior Secondary DAV School, Shalimar Bagh 1991
Professional Experience
1. Head Quality Assurance (2020 – 2023)
Sharp Mint Limited, Delhi, India
Validated manufacturing processes and analytical methods, identifying and addressing any loopholes or
deficiencies in the system.
Conducted management reviews meetings and facilitated regular HACCP, TACCP, and VACCP meetings,
ensuring that discussions were documented and circulated.
Coordinated the investigation of customer and internal complaints, and developed Corrective and Preventive
Actions (CAPA) for nonconforming products and customer complaints.
Organized and analyzed deviations, change controls, and out-of-specification situations, conducting risk
assessments and handling both planned and unplanned deviations effectively.
Worked on various sustainable platforms of ECOVADIS, SEDEX and Carbon Disclosure Projects. These
included sustainable procurement, environment monitoring (Carbon Dioxide Emission), Ethics, Health and Safety
Measures, Human Resource.
Worked for REACH Registration of Products for the company
Coordinated and prepared for DMF and Site Master File of the company
Good knowledge of EU Regulation, ICH and 21 CFR Guidelines
Worked for the certification for ISO 14001:2015 & ISO 45001:2018 and got certified the organization for the same
in 2023
Good knowledge of ISO 22000 :2018, FSSC 22000 and also trained Lead auditor for ISO 9001:2015
Review and approval of equipment qualification /calibration/ validation reports associated with Reference
Standards development and evaluation. Additionally, review and approval of in-house equipment qualification
protocols
Ensure good documentation practices followed as per ALCOA+ principle to paper and electronic records
Ensure adherence of Data Integrity Policy, Data Trail Reviews, Software Method Validation Protocols.
Gathering information from relevant functions including sales, marketing, production, dispatch, stores, purchase,
QC and R&D to understand the problem &address the root cause
2. Executive Director (Operations) (2016 - 2020)
Sharp Mint Limited, Delhi, India
Evaluated the performance of the unit, offering guidance and counseling as needed, and implemented measures
to ensure cost-effective operations.
Facilitated coordination and collaboration among different departments within the company, including marketing,
production, and purchasing, to achieve company-wide targets in terms of turnover and profitability.
Ensured optimal utilization of production resources while maintaining compliance with food safety regulations and
current Good Manufacturing Practices (cGMP).
3. Executive Director (Marketing & Sales) (2014 - 2016)
Sharp Mint Limited, Delhi, India
Developed and nurtured relationships with customers, addressing their inquiries and coordinating all customer
visits.
Monitored market trends and competitors, conducting market surveys to generate new ideas and identify
marketing opportunities for expanding the company's business portfolio.
Maintained a database of customer requirements, anticipated business from each customer, and competitor data,
effectively communicating customer delivery requirements to the planning cell to facilitate production plans.
4. Senior Vice President (Production) (2012 - 2014)
Sharp Mint Limited, Delhi, India
Enforced strict adherence to process parameters and ensured that all personnel followed gowning procedures
and food safety measures.
Collaborated with the Quality Assurance (QA) team in investigating non-conforming situations, customer
complaints, and audit non-conformities.
Planned, scheduled, and reviewed workload to ensure efficient utilization of time and cost-effective production-
related activities.
Implemented manufacturing improvement processes, policies, and systems to reduce inventory, increase
throughput, and minimize costs.
5. Head Quality Control (2008 - 2012)
Sharp Mint Limited, Delhi, India
Utilized various analytical techniques and instrumentation, including GC-MS (Gas Chromatography Mass Spectra)
and Gas Chromatography (GC), polarimeter, refractometer, melting point apparatus to perform analytical tasks.
Have gone through training of IQ,OQ, PQ etc.
Oversaw the quality control of incoming materials, in-process stages, and final inspections, ensuring the proper
release of products.
Supervised and managed the test laboratories of the company, including the retention/control samples from all
outgoing shipments.
Excellent knowledge of different pharmacopeia guideline viz. USP, BP, EP, IP etc.
Excellent knowledge of instrument calibration and qualification.
Handling of OOT and OOS results
6. Manager Quality Control (2000 - 2008)
Sharp Mint Limited, Delhi, India
Responsible for testing & coordinating with purchase for approval of raw material rec. and providing release order
for production.
Handled documentation, prepared dispatched material certificates (COA) and maintained AMC record of
analytical instruments.
Outsourced testing of samples and as per customer requirement and worked on strengthening QC SOP.
7. Approved Chemist (1997 - 2000)
Sharp Mint Limited, Delhi, India
Obtained certification as a government-recognized analytical chemist, specializing in pharmacopoeia testing.
Possess extensive expertise in calibrating various instruments including Melting Point apparatus, Karl Fisher
Titrator, polarimeter, Thermometer, and ensuring system suitability of GCs. Proficient in developing stability
protocols for finished goods (FG).
8. Chemist, Quality Control (1994 - 1997)
Sharp Mint Limited, Delhi, India
Conducted comprehensive physical and chemical testing of raw materials (RM), work-in-progress (WIP), and
finished goods (FG), which involved tasks such as documentation management, preparation of Standard
Operating Procedures (SOPs), and handling of equipment.
Performed stability studies on both finished goods (FG) and raw materials (RM), while also ensuring the proper
maintenance and calibration of the equipment used in these studies.
Certifications
ISO 9001:2015 QMS IRCA Lead Auditor Certification
Approved Chemist, Drug Controlled Dept. (NCT) (1997 - 2000)
Skills Acquired
• Auditing
• Monitoring Corrective and Preventive Actions (CAPA)
• Preparing flavors and fragrances blends
• Quality Control
• Risk Assessment and Management
• Project Management
• Regulatory Compliance
Interpersonal Skills:
• Dedication
• Discipline
• Effective decision-making
• Strong leadership abilities
• Excellent communication skills
Other Skills:
• Quantitative analysis
• Problem-solving expertise
Achievements
Successfully faced 4 US FDA audits in 2014, 2016, 2018 and 2020 respectively. Our organization is
first in World to be inspected by US FDA in Menthol and allied products.
Completed more than 500 quality management audits performed by various customers (Colgate,
Proctor & Gamble, Johnson & Johnson, Kraft, Mars, Wrigley, Reckit Benckiser, Astra Zeneca, Sanofi,
Kerry International, Takasago, Pfizer, and many others), regulators (Drug Licence, cGMP, COPP, WC
etc.) and certifying bodies for ISO 9001, ISO 14001, ISO45001, Kosher, Halal etc.
Lead the organization and got Silver Medal for the company in Ecovadis Platform 2023.
Was part of team in getting ISO 9001 and FSSC 22000 for the company.
Recently have got completed CQI and IRCA ISO9001:2015 Lead Auditor Training.
Sunita Sharma
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