Aculife Healthcare Hiring For Analytical Development Laboratory (ADL)

Aculife Healthcare Hiring For Analytical Development Laboratory (ADL)

We Are Hiring For Analytical Development Laboratory (ADL)

Designation:-Officer/Sr. Officer/Executive

Department:- Analytical Development Laboratory (ADL) 

Qualification:-M. Pharm/ Msc/B. Pharm

Experience:-1 To 8 Years Experience in Analytical Development in a regulated injectable pharmaceutical

Location:-ACULIFE HEALTHCARE PRIVATE LIMITED.

Near Railway Crossing (Sanand - Viramgam Highway) 

Village: Sachana, Taluka : Viramgam District: Ahmedabad – 382 150

Note:- Male & Female Both Can Apply 

JD:-

Job Purpose:-

To develop, validate, and transfer analytical methods for injectable formulations, ensuring compliance with cGMP, regulatory guidelines, and project timelines.

Key Responsibilities:

1) Analytical Method Development:-

 Develop and optimize analytical methods for injectable drug products using techniques such as HPLC, GC, UV, tc. Prepare and review method development protocols and reports.

2)Method Validation:-

Conduct analytical method validation as per ICH Q2(R1) and regulatory requirements. Document validation results and ensure accuracy, precision, specificity, and robustness.

3)Stability Studies:-

Plan and execute stability studies for injectable formulations. Analyze and document stability samples as per ICH Q1 guidelines.

4)Technology Transfer:-

Assist in analytical method transfer to QC or manufacturing facilities. Prepare method transfer protocols and reports.

5)Regulatory Documentation:-

Contribute analytical data and reports for regulatory submissions (CTD/ACTD/eCTD). Support in responding to regulatory queries and audits.

6) Instrument Handling:-

Operate and maintain analytical instruments. Ensure timely calibration and troubleshooting of equipment.

7)Compliance & Documentation:-

Maintain laboratory records in accordance with GLP and cGMP practices. Follow SOPs and ensure compliance with quality and safety standards.

Key Skills:

1) Strong expertise in HPLC/GC/UV method development and validation

2) Knowledge of ICH Guidelines, cGMP, GLP

3) Experience in stability studies, impurity profiling, method transfer

4) Good documentation and communication skills

5) Experience with regulatory audits (USFDA, EU, WHO-GMP) is a plus

 Interested Candidates Send Your Updated Cv on:-

recruitment@aculife.co.in & rajeshthakor@aculife.co.in 

Aculife Healthcare Hiring For Analytical Development Laboratory (ADL)