BSc & MSc Biotechnology Job Vacancies at Nectar Lifesciences Pvt Ltd
Company name : Nectar Lifesciences Pvt Ltd
Job Title : Quality Assurance (QMS) Quality management systems
Location : Himachal Pradesh (Solan)
Employment Type : Full-time
Qualification : B.Sc./M.Sc. in Life Sciences / Chemistry / Biotechnology OR B.Pharm / M.Pharm.
Experience :
- 2–6 years in QA (QMS) within a pharmaceutical/biotech formulations or API facility.
- Strong knowledge of cGMP, GLP, QMS guidelines, and regulatory frameworks (USFDA, MHRA, WHO, EU).
- Hands-on experience in document control, deviation management, CAPA, and audit handling.
Gender Preference : No such preference
Salary : Rs .25000 – 30000/Month
Job Summary:
The Quality Assurance (QMS) professional will be responsible for implementing, monitoring, and maintaining the Quality Management System in compliance with cGMP, ICH guidelines, and international regulatory standards. The role ensures that all manufacturing, testing, and distribution processes meet required quality, safety, and compliance standards. The candidate will oversee deviation management, CAPA, change control, documentation, and audit readiness, while supporting cross-functional teams to maintain a robust quality culture across the organization. This position requires strong knowledge of pharmaceutical regulations, documentation practices, data integrity, and risk-based quality systems, ensuring continuous improvement and regulatory compliance at Nectar Lifesciences.
Key Responsibilities:
Regulatory & Compliance Knowledge
• Strong understanding of cGMP, GLP, ICH Q10 (Pharmaceutical Quality System).
• Awareness of USFDA, MHRA, WHO, TGA, and EU guidelines.
• Knowledge of ISO standards (e.g., ISO 9001, ISO 13485 if applicable).
Quality Management System (QMS) Expertise
• Proficiency in document control, deviation, CAPA, and change control systems.
• Hands-on experience with risk management, OOS/OOT investigations, and quality metrics.
• Ability to manage and monitor SOPs, training records, and batch records.
• Exposure to quality review of validation/qualification documents.
Audit & Inspection Handling
• Experience in internal audits, external audits, and regulatory inspections.
• Preparing audit responses and ensuring timely closure of observations.
• Knowledge of data integrity (ALCOA+) requirements.
Documentation & Record Management
• Strong technical writing for quality manuals, policies, and procedures.
• Accurate review of batch manufacturing records (BMRs) and batch packaging records (BPRs).
• Proficiency in electronic QMS systems (e.g., TrackWise, MasterControl, SAP-QMS).
Analytical & Problem-Solving
• Root cause analysis and corrective/preventive action (CAPA) implementation.
• Risk-based thinking for quality decision-making.
• Identifying trends in deviations, complaints, and audit findings for continuous improvement.
Training & Cross-Functional Collaboration
• Conducting GMP/QMS training sessions for staff.
• Coordination with QC, Production, Engineering, and Regulatory Affairs.
• Strong communication & leadership skills to drive quality culture.
Soft Skills
• Detail-oriented with excellent organizational skills.
• Time management and ability to handle multiple priorities under pressure.
• Teamwork and leadership mindset for compliance-driven environment.
Requirements: Education: B.pharma , M.Pharma candidates
Experience: 2–6 years in QA (QMS) within a pharmaceutical/biotech formulations or API facility.
Skills:
Regulatory & Compliance Skills
• Strong understanding of cGMP, GLP, ICH Q10 (Pharmaceutical Quality System).
• Familiarity with USFDA, MHRA, WHO, EU GMP guidelines.
• Knowledge of data integrity (ALCOA+) principles.
QMS Expertise
• Hands-on experience in Deviation, Change Control, CAPA, OOS, OOT management.
• Proficiency in document control and SOP management.
• Knowledge of batch record review (BMR/BPR) and ensuring compliance before release.
• Risk management skills (identifying, assessing, mitigating quality risks).
Audit & Inspection Skills
• Experience in internal audits, regulatory inspections, and customer audits.
• Ability to prepare audit responses, compliance reports, and ensure closure of findings.
• Knowledge of audit trail review in electronic systems.
Documentation & Technical Writing
• Strong skill in drafting, reviewing, and maintaining quality manuals, policies, and procedures.
• Accuracy in reviewing technical documents, validation records, and regulatory submissions.
• Familiarity with electronic QMS systems (TrackWise, MasterControl, SAP-QMS preferred).
Analytical & Problem-Solving
• Root cause analysis and CAPA implementation skills.
• Trend analysis of deviations, complaints, and audit observations.
• Ability to implement continuous improvement initiatives.
Training & Quality Culture
• Conducting GMP and QMS-related trainings for employees.
• Promoting quality awareness across departments.
• Capability to collaborate with cross-functional teams (Production, QC, Engineering, Regulatory).
Soft Skills
• Strong attention to detail and organizational skills.
• Excellent communication and presentation skills.
• Time management, leadership qualities, and teamwork.
• Ability to work under pressure during audits and regulatory deadlines.
Interview Process:
• Mode: Direct Interview
• Rounds: 3 Rounds
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