14 Oct
|
JINDAL STEEL u0026 POWER
|
Baddi
14 Oct
JINDAL STEEL u0026 POWER
Baddi
(JD)Sr. Executive / Assistant Manager – ADL (R&D;)
Department: Research & Development (R&D;) – Analytical Development Laboratory (ADL)
Qualification: M.Sc. / M. Pharma
Industry: Pharmaceutical / Formulation Development
Experience: Relevant experience in Analytical Development Laboratory (ADL) within pharmaceutical R&D;
Job Summary
We are looking for a skilled and detail-oriented Sr. Executive / Assistant Manager – ADL (R&D;) to develop, validate, and execute analytical methods for raw materials, intermediates, and finished Oral Solid Dosage (OSD) products. The ideal candidate should have hands-on experience in analytical method development, method validation, stability studies, and regulatory compliance within the pharmaceutical industry.
Key Responsibilities
- Develop, optimize, and validate analytical methods for raw materials, intermediates, and finished pharmaceutical products, particularly OSD formulations.
- Perform routine and developmental analysis, including assay, dissolution, impurity profiling, and stability testing.
- Operate and troubleshoot analytical instruments such as HPLC, GC, UV-Visible spectrophotometers, and dissolution apparatus.
- Prepare and review analytical method development reports, method validation protocols, validation reports, and stability study documentation.
- Generate, review, and maintain accurate analytical data for regulatory submissions and technical documentation.
- Provide analytical support to formulation development, scale-up activities, and technology transfer.
- Ensure compliance with Good Laboratory Practices (GLP), ICH guidelines, applicable pharmacopoeial standards, and regulatory requirements.
- Maintain laboratory instruments and equipment,
ensuring timely calibration, qualification, and preventive maintenance.
- Investigate out-of-specification (OOS) and out-of-trend (OOT) results, analytical deviations, and laboratory discrepancies.
- Maintain laboratory documentation, data integrity, and standard operating procedures (SOPs).
- Coordinate with formulation development, quality assurance, quality control, and other cross-functional teams to support project timelines.
Required Skills and Competencies
- Solid knowledge of analytical method development and validation for pharmaceutical formulations.
- Hands-on experience with HPLC, GC, UV-Visible spectroscopy, and dissolution testing.
- Understanding of assay, related substances, impurity profiling, and stability studies.
- Knowledge of ICH guidelines, GLP, pharmacopoeial requirements, and regulatory documentation.
- Familiarity with OOS/OOT investigations, troubleshooting, and laboratory compliance.
- Strong analytical, problem-solving, documentation, and communication skills.
- Ability to manage multiple analytical activities while maintaining accuracy and quality standards.
Educational Qualification
- M.Sc. in Chemistry / Analytical Chemistry or a relevant discipline, or
- M. Pharma in a relevant specialization.
Preferred Candidate Profile
- Experience in pharmaceutical R&D;, specifically Analytical Development Laboratory (ADL).
- Exposure to Oral Solid Dosage (OSD) formulations.
- Practical knowledge of analytical method development, validation, stability studies, and technology transfer.
- Candidates with relevant experience in regulated pharmaceutical environments will be preferred.
Pay: ₹700,000.00 - ₹800,000.00 per year
Work Location: In person
📌 Sr. Executive/AM - ADL (R&D). (Baddi)
🏢 JINDAL STEEL u0026 POWER
📍 Baddi