Mepro Hiring QC, QA & Regulatory

B.Pharm/M.Pharm QC & RA Roles — Mepro, Vadodara

B.Pharm/M.Pharm, multiple vacancies for QC, QA & Regulatory roles at Mepro Pharmaceuticals (Unit-III), Vadodara. Apply now.

Mepro Pharmaceuticals Pvt. Ltd. (Unit-III) in Vadodara is hiring experienced life‑sciences professionals across Quality Control, Regulatory Affairs and QA. If you have a B.Pharm/M.Pharm or B.Sc/M.Sc in life sciences and practical experience with GMP, HPLC analysis, regulatory dossiers (CTD/ACTD) and QMS/CAPA handling — this could be the next career step that places you at the center of product quality and compliance for a company committed to humanity.

Company Overview

Mepro Pharmaceuticals Pvt. Ltd. is an established manufacturer in the Indian pharmaceutical industry with a clear focus on quality, regulatory compliance and patient safety. Unit‑III (Vadodara) operates with cGMP standards and a structured Quality Management System that supports routine manufacturing, testing, validation and global regulatory submissions. The company emphasizes process integrity, continuous improvement and training to maintain high standards of product quality and regulatory readiness.

Why Mepro stands out

• Demonstrable commitment to patient safety and public health.
• Structured QMS and cross‑functional collaboration between QC, QA and Regulatory teams.
• Ongoing focus on career development through training, validation exposure and dossier work.

Job Role & Responsibilities

Below are the open roles and their core responsibilities. Candidates should bring hands‑on technical skills and the ability to document activities in line with GMP and company SOPs.

Quality Control — Senior Executive (QMS / OOS/OOT / CAPA)

Key responsibilities:

• Lead investigations into OOS/OOT results, deviations and incidents.
• Prepare investigation reports, propose root‑cause analyses and assign CAPA.
• Single point of contact for QC QMS activities including change control and closure of corrective actions.
• Maintain QMS records, support audits and drive timely CAPA implementation.

What you must demonstrate:

• Proven track record in investigation and CAPA ownership.
• Strong documentation skills and familiarity with change control processes.

Quality Control — Assistant Manager (Analytical Method Validation & Tech Transfer)

Key responsibilities:

• Design and review analytical method validation and verification protocols and reports.
• Lead technical transfer activities and ensure analytical readiness at receiving sites.
• Coordinate protocol execution, interpret validation data and compile reports for QA review.
• Communicate effectively with cross‑functional teams.

What you must demonstrate:

• Hands‑on experience in method validation and method verification.
• Strong report writing and stakeholder communication skills.

Quality Control — Officer (Routine Analysis)

Key responsibilities:

• Perform routine analyses using HPLC and other analytical equipment.
• Perform incoming raw material (RM), packing material (PM), in‑process and stability testing per approved methods.
• Maintain accurate GMP documentation and support stability studies and sample management.

What you must demonstrate:

• Solid practical experience with HPLC operation, basic troubleshooting and sample preparation.
• Good understanding of GMP documentation (BMR/BPR) and laboratory workflows.

Regulatory Affairs — Executive / Asst. Manager / Dy. Manager

Key responsibilities:

• Prepare, review and submit regulatory dossiers in CTD/ACTD and country‑specific formats.
• Implement and track regulatory submissions and ensure compliance with ICH guidelines.
• Assess CMC changes, identify regulatory risks and propose mitigation strategies.
• Lead lifecycle management and product regulatory milestones.
• Contribute to SOP updates, regulatory data management and alignment with global requirements.

What you must demonstrate:

• Strong experience in dossier compilation and regulatory submissions.
• Ability to assess regulatory impact of CMC and manufacturing changes and propose compliant solutions.

Quality Assurance — Officer / Executive

Key responsibilities:

• Ensure cGMP compliance through IPQA checks, environmental monitoring and aseptic practice audits.
• Support validation activities, sterilization verification and audit responses.
• Review QA documentation including BMR/BPR and participate in training to maintain GMP behaviour.

What you must demonstrate:

• Hands‑on IPQA experience and familiarity with shop‑floor QA oversight.
• Experience supporting audits and executing QA documentation reviews.

Eligibility / Qualifications

Candidates should meet the following minimum eligibility criteria for the listed positions.

• QC Senior Executive / Asst. Manager / Officer: B.Sc (Chemistry/Biochemistry) or M.Sc (Analytical Chemistry/M.Sc) or equivalent. Practical HPLC experience required. Experience ranges: Officer 2–6 years, Senior Executive 8–10 years, Assistant Manager 10–12 years.
• Regulatory Affairs: B.Pharm/M.Pharm with 8–12 years of regulatory experience (CTD/ACTD dossier work preferred).
• QA Officer/Executive: B.Pharm/M.Pharm with 3–7 years of IPQA/QA experience.

Relevant courses (comma‑separated): B.Pharm, M.Pharm, B.Sc (Chemistry), M.Sc (Analytical Chemistry), Diploma in Pharmaceutical Quality Assurance, Postgraduate Diploma in Regulatory Affairs, Certificate in Pharma Validation, MSc Biotechnology, B.Sc Microbiology, B.Sc Biochemistry

Skills & competencies we value:

• Strong analytical and problem‑solving ability.
• Clear technical report writing and documentation skills.
• Deep working knowledge of GMP, QMS, CAPA, change control and audit readiness.
• Good communication skills and cross‑functional stakeholder management.

Location & Salary

Location: Unit‑III, Vadodara, Gujarat.

Salary: Salary will be competitive and commensurate with experience and role. Exact salary bands are discussed during the interview and offer stage. (Candidates with strong analytical validation, regulatory submission experience or proven QMS leadership may negotiate for above‑market compensation.)

Application Process

Interested candidates should email their CV to: careers@mepro.in. Please use the subject line that clearly mentions the department you are applying for (e.g., “QC — Sr. Executive” or “Regulatory — Asst. Manager”).

Application checklist:

• Updated CV with clear timeline of experience.
• Copies of relevant educational certificates and training (on request).
• Brief cover note (2–3 lines) summarizing your key suitability for the role.

FAQs

Q: What are the minimum qualifications for Regulatory Affairs roles?
A: Typically B.Pharm or M.Pharm with 8–12 years of experience in CTD/ACTD dossier preparation, regulatory submissions and lifecycle management.

Q: Can freshers apply?
A: The current vacancies target experienced candidates (2+ years for QC Officer; senior and managerial roles require 8+ years). Mepro periodically opens entry‑level roles — check back or follow company careers updates.

Q: What is the selection process?
A: Shortlisted candidates will be contacted for telephonic screening, followed by technical interviews and HR discussion. Relevant technical assessments or case studies (method validation write‑up, CAPA analysis, dossier excerpt) may be requested.

Q: Is remote work available?
A: These roles require on‑site presence at Unit‑III, Vadodara due to lab and manufacturing responsibilities.

Q: What documents should I attach?
A: Updated CV, brief cover note, and scanned copies of degree certificates or relevant training if available.

Q: Are salary ranges disclosed?
A: Salary is competitive and based on experience. Strong candidates with advanced validation or regulatory expertise may have scope for higher compensation during offer negotiations.

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+----------------------+---------------------------------------------------------------+
| Company              | Mepro Pharmaceuticals Pvt. Ltd. (Unit-III), Vadodara          |
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| Vacancies            | Multiple vacancies across QC, QA, Regulatory Affairs          |
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| Required Education   | B.Pharm, M.Pharm, B.Sc, M.Sc (Analytical Chemistry), Diploma   |
+----------------------+---------------------------------------------------------------+
| Experience           | QC Officer: 2–6 yrs; QC Sr. Exec: 8–10 yrs; RA: 8–12 yrs; QA: 3–7 yrs |
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