Quality Control Specialist

Pharmapodium; Washim; Sur place; INR 600 000 - 1 000 000; Plein temps

Résumé du poste

Pharmapodium in Maharashtra seeks a QC/Lab Specialist with 7–12 years in pharma/chemical QC. You will operate and troubleshoot HPLC, manage CDS data, and ensure GMP/GLP compliance. The role involves training analysts, supporting audits, and handling OOS/OOT investigations with cross-site collaboration.

The candidate should hold B.Sc or M.Sc in Chemistry, and Marathi language proficiency is mandatory. Experience with GC and UV-Vis is desirable, with strong documentation skills and stakeholder

Qualifications

• 7–12 years in a quality control laboratory, preferably pharma/chemical.
• Marathi candidates only; strong communication and documentation skills.
• Hands-on experience with HPLC, GC, and related analytical techniques.
• Knowledge of cGMP/GLP and data integrity principles.

Responsabilités

• Operate and troubleshoot HPLC; ensure system suitability and data integrity.
• Perform instrument calibration, preventive maintenance, and IQ/OQ/PQ.
• Maintain ALCOA+ compliant records and audit trails.
• Review COAs and test protocols from internal/third-party labs.
• Support regulatory audits and internal QC audits; train analysts as needed.
• Carry out sample analysis for QC, batch release support, and R&D samples.
• Coordinate with vendors for service contracts and calibration.
• Handle OOS/OOT investigations and method verification/transfer.
• Prepare quality reports and maintain GMP-compliant documentation.
• Work across manufacturing sites within India as required.

Connaissances

HPLC operation

Troubleshooting

CDS knowledge

OOS/OOT investigations

Calibration & qualification

GMP/GLP compliance

Data integrity (ALCOA+)

Vendor coordination

Training & mentoring

Documentation & reports

Formation

B.Sc Chemistry

M.Sc Chemistry

Outils

CDS (Chromatography Data System)

GC

UV-Vis Spectroscopy

MS Office

Description du poste

Role & responsibilities

• Strong hands-on experience in HPLC operation and troubleshooting.
• Expertise in handling analytical instruments and Chromatography Data Systems (CDS).
• Experience in calibration, preventive maintenance, and instrument qualification activities.
• Knowledge of AMC/service contract management and vendor coordination.
• Experience in electronic data management, audit trail review, data backup, and restoration.
• Good understanding of ALCOA+ principles, data integrity requirements, GMP, and GLP compliance.
• Experience in OOS/OOT investigations, method validation, method verification, and method transfer activities.
• Ability to independently troubleshoot HPLC issues such as pressure fluctuations, peak shape problems, retention time variation, carryover, baseline noise, ghost peaks, and system suitability failures.
• Experience in supporting regulatory, customer, and internal audits.
• Capability to train and guide QC analysts on HPLC operation and troubleshooting
• Extra sample & out party sample analysis arrangement.
• Batch release responsibility in absence of Quality head.
• R & D samples analysis on GC & HPLC.
• Instrument maintenance Responsibility.
• Market complaint Sample analysis activity.
• Responsible for Batch Release.
• Handling OOS, OOT, OOC & Deviation.
• Vendor assessment sample management.
• IPQC review.
• Responsible for Promotional sample.
• Laboratory monitoring.
• Responsible for Release GRN.
• Any job activity assigned by HOD.
• Review and verify test protocols, COAs received from the third-party laboratory.
• To ensure GLP and GDP in QC Lab.
• To ensure the Safety in QC Lab.

Training

• Impart training on Safety to new recruits, employees, contractors, contract employees.
• Periodically evaluate Training Effectiveness.
• Maintain updated records for all the Training activities

Preferred candidate profile

Qualified candidates will have:

Mandatory requirements: Marathi Candidates only

• Education requires, B.SC / M.SC Chemistry.
• Minimum of 7-12 years of experience in a quality control laboratory, preferably in the pharmaceutical industry / Chemical Industry.
• Relevant Experience in Quality Laboratory in Pharma / Chemical Industry
• English fluency, both written and spoken
• Excellent problem-solving skills and attention to detail.
• Strong communication and documentation skills.
• Ability to work independently and as part of a team
• Proficiency in analytical techniques such as HPLC, GC, and UV-Vis Spectroscopy
• Strong understanding of cGMP, GLP, and other regulatory guidelines
• Knowledge of MS Office / Quality Reports
• Preparing Quality reports & documents
• Fluence in working with different stakeholders within a manufacturing facility within a matrix organization
• Flexibility & Agility within the organization, working at different manufacturing sites within India

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