Encube Hiring Sr. Officer MES

B.Pharm Sr. Officer MES – Encube Ethicals, Indore

B.Pharm Sr. Officer MES at Encube Ethicals. 1 vacancy in Indore. Apply with 2–5 years QA/MES experience.

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Encube Ethicals is recruiting a motivated Senior Officer – MES (Master Batch Record) to strengthen its Quality Assurance (QA) capability in Indore. This role is ideal for B.Pharm professionals with 2–5 years of practical QA/MES experience who want to lead electronic batch documentation initiatives, ensure data integrity, and enable efficient, auditable manufacturing processes.

Company Overview

Encube Ethicals is a progressive pharmaceutical manufacturer focused on delivering high‑quality, patient‑centric formulations. The company emphasizes regulatory excellence (GxP), manufacturing discipline, and digital transformation to reduce manual paperwork and improve traceability. Encube’s collaborative culture sits at the crossroads of QA, manufacturing, and IT — providing an ideal environment for professionals who enjoy hands‑on problem solving and implementing validated systems that directly impact product safety and compliance.

The company is actively investing in Manufacturing Execution Systems (MES) and electronic Master Batch Records (MBRs) to accelerate batch turnaround times, strengthen audit readiness, and build robust data integrity controls across production operations.

Job Role & Responsibilities

As Senior Officer – MES (MBR) you will be the QA subject matter expert for electronic Master Batch Records and MES workflows. You will design, validate, deploy, and maintain MBR templates and ensure the MES supports accurate, auditable data capture across manufacturing operations.

Primary Responsibilities:

• Design & Develop Electronic Master Batch Records (MBRs): Convert approved batch recipes, process steps, and control strategies into validated electronic MBR templates that are clear, operator‑friendly, and compliant.
• MBR Testing, Qualification & Validation: Author test protocols, execute IQ/OQ/PQ, lead UAT, and compile validation evidence to meet company and regulatory expectations.
• MES Workflow Troubleshooting & Optimization: Investigate MES exceptions, lead root‑cause analysis, propose corrective actions, and refine workflows to minimize deviations and rework.
• Cross‑functional Collaboration: Collaborate with Quality, Production, Process Development, and IT teams to ensure MES accurately reflects manufacturing realities and control strategy.
• User Training & Change Management: Develop training material, deliver hands‑on sessions for operators and supervisors, and update SOPs and user guides to support MES adoption.
• Template Maintenance & Continuous Improvement: Manage MBR versioning, capture user feedback, and implement change controls that improve usability and reduce human error.
• Regulatory & Data Integrity Compliance: Ensure all MES activities align with GxP, ALCOA+/data integrity principles, audit trail requirements, and applicable regulatory guidance.

This role calls for a professional who can translate complex manufacturing processes into robust electronic workflows, write clear validation artefacts, and train shop‑floor users to operate within an auditable digital system.

Eligibility / Qualifications

Minimum Educational Qualification:

• B.Pharm (Mandatory). Candidates with M.Pharm, Diploma in Pharmacy, or relevant engineering degrees with pharma QA experience will be considered.

Experience:

• 2–5 years in Quality Assurance, MES implementation, validation, or production documentation in a regulated pharmaceutical environment. Practical experience in MBR design and MES validation is essential.

Technical Competencies:

• Hands‑on exposure to MES platforms; experience with Werum PAS‑X or similar commercial MES is a plus.
• Strong understanding of GxP, validation lifecycle (IQ/OQ/PQ), CSV (computer system validation) principles, and data integrity (ALCOA/ALCOA+).
• Ability to author test scripts, execute UAT, and prepare comprehensive validation packages.
• Familiarity with manufacturing of semi‑solid dosage forms is beneficial but not mandatory.

Soft Skills:

• Clear written and verbal communication for SOPs, training, and stakeholder engagement.
• Analytical mindset with strong problem‑solving and documentation skills.
• Collaborative attitude and ability to work effectively with cross‑functional teams.

Relevant Courses (comma-separated):
B.Pharm, M.Pharm, Diploma in Pharmacy, B.Tech (Pharmaceutical/Chemical), Certificate in Quality Assurance, Certificate in Validation & Regulatory Affairs, PG Diploma in Pharmaceutical Management, Certificate in MES/Werum PAS‑X Fundamentals

Location & Salary

Work Location: Indore (On‑site)
Employment Type: Full‑time — Senior Officer level within Quality Assurance.
Compensation: Encube Ethicals offers compensation aligned with Indore market benchmarks. Exact salary will be determined based on experience, demonstrated MES skills, and interview performance. Benefits typically include statutory contributions, health coverage, and support for professional development.

Note: This role requires on‑site presence due to validation activities, operator training, and close collaboration with production and IT teams.

Application Process

To apply, candidates should email a detailed CV that highlights their MES/MBR and validation experience. Include examples of MBR templates you developed, validation packages authored, and any MES software you have used.

How to Apply:

• Email: rashi.bhatia@encubeethicals.com
• Subject Line: “Application – Sr. Officer MES – [Your Name]”
• Attach: Resume, degree certificate, and any relevant MES/validation training certificates.

Selection Stages:

1. Resume shortlisting based on technical fit and experience.
2. Telephonic screening by HR.
3. Technical interview covering MES workflows, validation approach, and practical case studies.
4. Final discussion with QA leadership and HR for compensation and offer.

Apply early — the recruitment team reviews applications on a rolling basis and may close the vacancy when a suitable candidate is selected.

Why This Role Matters (EEAT Focus)

The Senior Officer – MES role is central to ensuring safe, compliant pharmaceutical manufacturing. By developing, validating, and maintaining electronic Master Batch Records, you will:

• Improve data integrity and audit readiness, ensuring that manufacturing records are complete, consistent, and accurate.
• Accelerate batch cycle times and reduce manual errors by enabling structured digital workflows.
• Support regulatory inspections and internal audits with clear, validated documentation.
• Contribute to patient safety by ensuring processes are executed as intended and deviations are minimized.

This position strengthens your domain expertise (E), positions you as an authoritive contributor to operational controls (A), and builds trust (T) through validated, compliant documentation and reproducible batch outcomes.

FAQs

Q1. Is B.Pharm mandatory for this role?
A1. Yes. B.Pharm is the minimum educational qualification. Candidates with higher pharma degrees or relevant engineering backgrounds with significant MES/QA experience may also be considered.

Q2. Do I need Werum PAS‑X experience?
A2. Direct Werum PAS‑X experience is beneficial but not strictly required. Practical experience with any MES platform and demonstrated MBR/validation experience are the key requirements.

Q3. Is this position open to freshers?
A3. No. This is a mid‑level role requiring 2–5 years of hands‑on experience in QA/MES/validation.

Q4. Will the company provide MES training?
A4. Encube provides onboarding and role‑specific training; however, candidates should already have baseline MES or validation exposure to be effective from day one.

Q5. Can remote work be considered?
A5. Due to hands‑on validation, operator training, and close coordination with production, this is primarily an on‑site role.

Q6. How soon will I hear after applying?
A6. Shortlisted candidates are typically contacted within 1–2 weeks, though exceptional candidates may be called sooner as applications are reviewed on a rolling basis.

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Company	Encube Ethicals
Vacancies	Senior Officer – MES (Master Batch Record)
Required Education	B.Pharm (M.Pharm, Diploma in Pharmacy, B.Tech considered)
Experience	2–5 Years