Key Responsibilies:

1. Analycal Method Development

• Independently develop and opmize analycal method for Assay, Related substance,

dissoluon, content uniformity using HPLC, GC, UV and dissoluon systems.

• Design and execute analycal method validaon, verificaon and robustness studies as

per ICHQ2(R1/R2)

• Perform and evaluate analycal force degradaon and stability-indicang methods.

• Lead method transfers and co-validaon acvies with external labs; resolve transfer

discrepancies.

• Review, approve and prepare method development, validaon protocols, reports and

SOPs.

• Invesgate and provide scienfic jusficaon for OOS, OOT, deviaons and change

controls related to analycal methods.

• Collaborate with formulaon, QA, regulatory and manufacturing teams to support project

melines.

2. Documentaon Acvies:

• Assist in the preparaon and review of:

• Prepare and review of analycal method development (AMD) protocols.

• Documentaon of method opmizaon trials and scienfic raonale.

• Preparaon of method development reports with chromatograms.

• Preparaon of Cerficates of Analysis (COAs), Standard Tesng Procedures (STPs),

Specificaon and technical documents.

• Bioequivalence (BE) NOC and import license related documentaon.

3. Instrument and Laboratory documentaons:

• Review of IQ/OQ/PQ protocols and reports for analycal instruments.

• Instruments calibraon, qualificaon and maintenance records.





• Audit trial review and documentaon for computerized systems.

4. Cross-naonal and Regulatory support.

• Provide analycal support to cross-naonal project teams across UK, EU and other

regulated markets.

• Coordinate with Regulatory affairs, QA, Formulaon team for analycal strategy, method

selecon and life cycle management.

• Ensure analycal methods comply with ICH guidelines, pharmacopeial requirements (EP,

BP) and country -specific regulatory expectaons.

5. Compliance & Safety:

• Follow Good Laboratory Pracces (GLP) and Good Documentaon Pracces (GDP).

• Comply with applicable regulatory and company safety guidelines.

• Maintain cleanliness and orderliness in the laboratory and documentaon areas.

Qualificaon & Skills Required:

• M.Sc. (Analycal chemistry) /M.Phram (Pharmaceucal Analysis)

• Sound academic background in analycal chemistry and pharmaceucal analysis

• Strong experse in analycal method development and troubleshoong

• Clear and effecve verbal and wrien commutaon for technical and non-technical

stakeholders

• Proficient in MS Office (Word, Excel, Outlook).

• Willingness to learn and adapt in a regulated environment.

Key Aributes:

• Strong aenon to detail

• Positive organizaonal and me management skills

• Posive atude and team player

• Eagerness to grow in the analycal domain

📌 Senior Research Associate - ADL (Vadodara)
🏢 B&S Group
📍 Vadodara