Role & responsibilities

- Solid 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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📌 Quality Control Specialist (Malegaon)
🏢 Pharmapodium
📍 Malegaon