India's DMPLOI - Jobs & Networking AppRoyal Pharma has announced an excellent career opportunity for experienced pharmaceutical professionals in the Analytical Development Laboratory (ADL) department. The company is looking for skilled candidates with expertise in analytical method development, validation, and laboratory operations for its Boisar, Maharashtra facility.
If you have experience in API or Advanced Intermediates manufacturing and possess strong knowledge of HPLC, GC, and regulatory guidelines, this opportunity could be an excellent step in your career.
Job Overview
Particular Details
Company Name
Royal Pharma
Position
ADL Executive / Chemist
Department
Analytical Development Laboratory (ADL)
Industry
Pharmaceutical (API & Advanced Intermediates)
Location
Boisar, Maharashtra
Experience
3–6 Years
Qualification
M.Sc. Chemistry or Equivalent
Job Responsibilities
Selected candidates will be responsible for:
Perform analytical method development and method validation for APIs and Advanced Intermediates.
Conduct routine analysis using HPLC, GC, UV-Vis, Karl Fischer (KF), and other analytical instruments.
Prepare, review, and maintain analytical protocols, reports, specifications, and laboratory documents.
Support R&D and process development through analytical studies.
Execute method transfer and troubleshoot analytical methods.
Ensure compliance with cGMP, GLP, GDP, and Data Integrity requirements.
Handle laboratory investigations including OOS, OOT, deviations, and CAPA activities.
Maintain laboratory documentation according to quality standards.
Eligibility Criteria
Candidates should have:
M.Sc. in Chemistry or equivalent qualification.
3–6 years of experience in Analytical Development Laboratory (ADL).
Strong knowledge of HPLC, GC, analytical method development, and validation.
Understanding of ICH Guidelines and pharmaceutical regulatory requirements.
Good documentation and problem-solving skills.
Strong focus on quality, data integrity, and compliance.
Ability to work effectively within a team and meet project timelines.
Required Technical Skills
Analytical Method Development
Method Validation
HPLC Operation
Gas Chromatography (GC)
UV-Visible Spectroscopy
Karl Fischer Titration
cGMP Compliance
GLP & GDP Documentation
Data Integrity
OOS/OOT Investigation
CAPA Management
ICH Guidelines
Salary
Salary will be discussed during the interview and will depend on qualifications, technical expertise, and relevant experience.
Work Location
Boisar, Maharashtra
How to Apply
Interested candidates can share their updated CV to:
Email: sonampawar@royalpharma.in
Why Join Royal Pharma?
Career growth in the pharmaceutical API sector.
Exposure to advanced analytical instruments.
Opportunity to work on R&D and method development projects.
Professional learning environment with quality-focused operations.
Strong emphasis on compliance and technical excellence.
Technical FAQs
1. What analytical instruments should candidates be proficient in?
Candidates should have hands-on experience with HPLC, GC, UV-Vis Spectrophotometer, Karl Fischer Titrator, and other routine analytical laboratory equipment used in pharmaceutical quality control and development.
2. What is analytical method validation?
Analytical method validation is the documented process of proving that an analytical method consistently produces reliable, accurate, precise, specific, linear, and robust results according to ICH Q2 guidelines.
3. What are OOS and OOT investigations?
OOS (Out of Specification): Test results falling outside approved specifications.
OOT (Out of Trend): Results within specifications but significantly different from historical trends, requiring investigation.
4. Why are cGMP, GLP, and GDP important in pharmaceutical laboratories?
These quality systems ensure product quality, laboratory integrity, accurate documentation, regulatory compliance, and patient safety throughout pharmaceutical manufacturing and testing.
5. What is method transfer in pharmaceutical analytical laboratories?
Method transfer is the documented process of transferring a validated analytical method from one laboratory to another while demonstrating equivalent performance and reproducibility under predefined acceptance criteria.
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