Meenakshi
Baddi
Summary
Experienced Quality Assurance leader with over 10 years in pharmaceutical manufacturing and healthcare compliance, specialising in GMP, QMS, audits, and regulatory documentation. Expertise in SOP development and complaint handling ensures product safety and regulatory alignment. Background in science education enhances communication and instructional capabilities. Strong in data management and process optimisation, fostering efficiency in remote QA and administrative roles.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Quality Head
Biosafe Medical India Pvt. Ltd
Ranchi
05.2021 - 03.2024
- Spearheaded QA operations for pharmaceutical products, ensuring full compliance with national and international GMP standards.
- Led internal and external audits, implemented CAPA strategies, and maintained audit readiness across all departments.
- Developed and enforced SOPs for production, packaging, quality control, ensuring consistent adherence to quality standards.
- Supervised batch release documentation, coordinating with regulatory bodies to secure timely product approvals.
- Trained QA personnel on documentation protocols and deviation handling, enhancing team's capability in risk mitigation.
Science Educator
Amravati Vidyalaya
Baddi, India
02.2019 - 04.2021
- Delivered science instruction in CBSE-affiliated schools, enhancing bilingual education and interactive learning experiences.
- Institutions include: St. Stephen's Academy, Lucknow; Amravati Vidyalaya, Baddi.
- Planned and prepared engaging lessons, motivating students and maximising their learning potential.
- Established high standards of discipline and positive behaviour expectations through focused teaching strategies.
Quality assurance manager
Alliance
Baddi
08.2013 - 03.2016
- Reviewed and updated quality assurance policies and procedures to ensure compliance with evolving regulations and best practices.
- Facilitated training sessions for staff on quality assurance best practices, enhancing understanding and implementation of company policies.
- Prepared detailed quality reports for senior management, highlighting performance metrics and identifying trends for targeted improvements.
- Established key performance indicators for quality assurance processes, enabling focused improvements and benchmarking success.
QA & Formulation Officer
Ravenbhel Healthcare Pvt. Ltd
Jammu
08.2011 - 03.2013
- Conducted formulation trials for new product development, enhancing product stability and compatibility.
- Drafted and reviewed quality documentation, ensuring compliance with industry standards in BMRs, BPRs, and validation protocols.
- Supported analytical method validation and collaborated with R&D, facilitating accurate dossier compilation.
- Ensured compliance with regulatory standards for domestic and export formulations.
- Participated in vendor audits and raw material quality evaluations.
Quality Assurance Executive
Arbro Pharmaceuticals Ltd
New Delhi
04.2010 - 03.2011
- Executed internal audits and reviewed SOPs to ensure compliance and enhance quality standards in manufacturing and quality control departments.
- Monitored batch documentation and ensured adherence to GMP during production cycles.
- Coordinated with QC and production teams for deviation analysis and corrective actions.
- Maintained regulatory documentation for product registration and licensing to support compliance and facilitate timely approvals.
Quality Assurance Executive
Radicura Pharmaceuticals Pvt. Ltd
New Delhi
03.2009 - 02.2010
- Conducted in-process quality checks for non-sterile dosage forms, ensuring compliance with quality standards.
- Implemented GMP protocols and conducted training sessions for production staff.
- Managed documentation for batch records, change controls, and equipment calibration, facilitating regulatory compliance and operational integrity.
- Supported validation activities, ensuring traceability of raw materials and finished goods to uphold quality assurance standards.
Education
B.Ed - Bachelors in education
Himachal Pradesh University
Shimla01-2019
Masters - Biotechnology
H. N. B. Garhwal University
Dehradun01-2009
Bachelor of Science - Biotechnology
Kurukshetra University
Kurukshetra, IN-HR01-2006
Skills
- Quality assurance compliance
- Regulatory compliance
- Total quality control
- Process improvement
- Root cause analysis
- Data management proficiency
- Quality Coaching
- Remote collaboration tools
- Professional Strengths: Cross-functional collaboration, problem-solving, adaptability, time management, strong written and verbal communication
Languages
English
Hindi
Kashmiri
Certification
- CTET Qualified – Central Teacher Eligibility Test (CBSE) -Paper I
Interests
- Scientific Reading & Research
- Educational Volunteering & Mentoring
- Technical Writing & Documentation
- Data & Analytics Exploration
- Professional Development & Webinars
- Creative Teaching Methods
- Community Engagement & Translation
Timeline
Quality Head
Biosafe Medical India Pvt. Ltd
05.2021 - 03.2024
Science Educator
Amravati Vidyalaya
02.2019 - 04.2021
Quality assurance manager
Alliance
08.2013 - 03.2016
QA & Formulation Officer
Ravenbhel Healthcare Pvt. Ltd
08.2011 - 03.2013
Quality Assurance Executive
Arbro Pharmaceuticals Ltd
04.2010 - 03.2011
Quality Assurance Executive
Radicura Pharmaceuticals Pvt. Ltd
03.2009 - 02.2010
B.Ed - Bachelors in education
Himachal Pradesh University
Masters - Biotechnology
H. N. B. Garhwal University
Bachelor of Science - Biotechnology
Kurukshetra University