Macleods Hiring M.Pharm/MSc Analytical

Macleods pharmaceuticals limited; Mumbai; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Macleods Pharmaceuticals Ltd. in Mumbai is seeking an Analytical Validation – API (HPLC) Professional with 2–6 years of hands-on AMV experience to ensure regulatory-compliant validation across API products. You will calibrate HPLC instruments, prepare validation protocols, and support regulatory audits in a GMP/GLP environment.

Join a dynamic API division in Mumbai and contribute to analytical excellence, instrument qualification, and lifecycle management of validation activities.

Qualifications

• 2–6 years of hands-on AMV experience for API products.
• Strong exposure to HPLC-based method validation and calibration.
• Experience in a regulated pharma environment is required.

Responsibilities

• Execute analytical method validation (AMV) for API products.
• Calibrate and qualify analytical instruments (HPLC, dissolution apparatus).
• Prepare and review validation protocols, raw data sheets, and reports.
• Ensure validation activities meet regulatory guidelines and pharmacopeial standards.
• Support method transfer from R&D or external labs to manufacturing sites.
• Troubleshoot HPLC methods and validation studies.
• Maintain GMP/GLP-compliant documentation and data integrity.
• Assist regulatory audits and inspections with documentation.

Skills

Analytical Method Validation (AMV)

HPLC operation & calibration

Dissolution testing

Validation documentation

Method transfer

Regulatory compliance

Education

M.Pharm

M.Sc (Analytical Chemistry)

Tools

HPLC

Dissolution Apparatus

Job description

M.Pharm/MSc Analytical Validation API Vacancy – Mumbai

M.Pharm/MSc Analytical Validation API HPLC vacancy with 2–6 years experience in Mumbai. Apply for pharma analytical validation role.

Macleods Pharmaceuticals is inviting experienced analytical professionals to join its API division for Analytical Validation roles based in Mumbai. This opportunity is ideal for M.Pharm and M.Sc professionals looking to strengthen their careers in regulatory-compliant analytical validation, HPLC method validation, and API quality systems within a reputed pharmaceutical organization.

Company Overview

Macleods Pharmaceuticals Ltd. is one of India’s fastest-growing pharmaceutical companies with a strong presence in regulated markets, including the US, Europe, and emerging economies. Known for its robust manufacturing capabilities, regulatory compliance, and quality-driven culture, Macleods operates across APIs, formulations, and specialty products.

The company places strong emphasis on analytical excellence, regulatory compliance, and continuous improvement, making it a preferred employer for professionals seeking long-term growth in pharmaceutical quality and validation functions.

Job Role & Responsibilities

As an Analytical Validation – API (HPLC) Professional, you will be responsible for ensuring analytical method compliance, validation accuracy, and regulatory readiness across API products.

Key responsibilities include:

• Execution of analytical method validation (AMV) for API products
• Calibration and qualification of analytical instruments such as HPLC, Dissolution Apparatus, and related equipment
• Preparation and review of validation protocols, raw data sheets, and analytical validation reports
• Ensuring validation activities are aligned with regulatory guidelines and pharmacopeial standards
• Supporting method transfer activities from R&D or external laboratories to manufacturing sites
• Troubleshooting analytical issues related to HPLC methods and validation studies
• Maintaining complete documentation in compliance with GMP, GLP, and data integrity requirements
• Supporting regulatory audits and inspections through accurate analytical documentation

Eligibility / Qualifications

Educational Qualification

• M.Pharm
• M.Sc (Analytical Chemistry or related discipline)

Relevant courses include:
M.Pharm (Pharmaceutical Analysis), M.Sc Analytical Chemistry, M.Sc Chemistry, Pharmaceutical Quality Assurance, Pharmaceutical Sciences

Experience Requirements

• 2 to 6 years of hands‑on experience in Analytical Validation – API
• Strong exposure to HPLC‑based method validation and instrument calibration
• Experience working in a regulated pharmaceutical environment

Key Skills

• Analytical Method Validation (AMV)
• HPLC operation, troubleshooting, and calibration
• Dissolution testing and analytical instrumentation handling
• Validation documentation and report preparation
• Method transfer and lifecycle management
• Understanding of regulatory requirements and compliance standards

Location & Salary

• Job Location: Andheri, Mumbai
• Employment Type: Full‑time
• Salary: As per industry standards and experience (Negotiable)

Frequently Asked Questions (FAQs)

Is HPLC experience mandatory for this role?
Yes. Strong hands‑on experience in HPLC method validation and calibration is essential.

Is this role focused on API or formulation analysis?
This role is specifically focused on API analytical validation.

Does the role involve regulatory documentation?
Yes. Preparation and review of validation protocols, data sheets, and reports are key responsibilities.

Is Mumbai location mandatory?
Yes. This position is based in Andheri, Mumbai.

What kind of regulatory exposure is expected?
Candidates should have experience working under GMP and regulatory‑compliant environments.