Qc Chemist

JOB DESCRIPTION-QC ANALYTICAL CHEMIST (3-5 Years)

JOB DESCRIPTION

Quality Control-Analytical chemist

Experience: 3-5 Years

Industry: Pharmaceutical/API Manufacturing

Location: Giochem Industries Pvt. Ltd, Bollaram

1. Job Purpose

To perform and review routine and non-routine analytical activities in the Quality Control laboratory in accordance with approved specifications, analytical methods, SOPs, GMP requirements, and applicable regulatory guidelines, ensuring timely and accurate release of raw materials, in-process materials, intermediates, finished and stability products.

2. Key Responsibilities

• Perform analysis of raw materials, intermediates, in-process samples, finished products, stability samples, and validation samples as per approved specifications and analytical methods.
• Handle and operate analytical instruments such as HPLC, GC, UV, FTIR, KF, pH meter, PSD and other laboratory instruments as applicable.
• Ensure proper execution of analysis within the defined turnaround time (TAT).

• Support method validation, method verification, method transfer, and analytical method troubleshooting activities.

• Participate in investigation of OOS, OOT, deviations, laboratory incidents, and atypical results and provide technical inputs.

• Maintain complete and accurate laboratory documentation in accordance with GMP and data integrity requirements.

• Ensure compliance with ALCOA++ principles and applicable regulatory requirements.

• SUpport preparation and review of analytical reports, worksheets, logbooks, and other QC documentation.

• Ensure proper handling, identification, storage, and disposal of samples and laboratory chemicals.

• Maintain laboratory housekeeping, 5S, safety, and good laboratory practices (GLP).

• Ensure instruments and laboratory equipment are maintained, calibrated, and available for routine analysis.

• Support customer audits, regulatory inspections, and internal audits by providing required analytical records and technical information.

• Identify opportunities for process improvement, laboratory efficiency, cost reduction, and continuous improvement/Kaizen.

• Train and guide junior QC analysts on analytical procedures, instrument operation, documentation, and safety practices.

• Ensure timely completion of assigned activities and communicate any deviations or delays to the reporting manager.

3. Technical Skills

• Good working knowledge of HPLC and GC analytical techniques.

• Knowledge of chromatographic data systems such as Empower/Chromeleon is preferred.

• Knowledge of UV, FTIR, KF, pH, PSD and other common QC instruments.

• Understanding of analytical method principles, system suitability, standardization, calculations, and troubleshooting.

• Basic understanding of analytical method validation/verification and method transfer.

• Knowledge of ICH guidelines, pharmacopoeial requirements (IP/BP/USP/Ph.Eur.) and GMP requirements.

• Good understanding of OOS/OOT investigation and laboratory investigations.

• Working knowledge of data integrity and ALCOA+ principles.

4. Educational Qualification

Essential:

M.Sc. in Chemistry, Organic Chemistry, Analytical Chemistry.

Preferred:

M. Pharma/equivalent qualification with relevant pharmaceutical QC experience.

5. Experience

• 3-5 years of relevant experience in Quality Control Laboratory in a pharmaceutical API or formulation manufacturing environment.

• Experience in handling HPLC/GC and routine pharmaceutical analytical activities is preferred.

• Experience in regulated GMP environments and exposure to customer/regulatory audits will be an added advantage.

6. Behavioral & Soft Skills

• Good analytical and problem-solving skills.

• Ability to work effectively with cross-functional teams.

• Strong attention to detail and commitment to data accuracy.

• Ability to prioritize activities and meet timelines.

• Willingness to work in shifts (A, B, C), wherever required.

• Positive attitude towards learning, teamwork, and continuous improvement.

• Strong commitment to quality, safety, compliance, and integrity.

7. Key Performance Indicators (KPIs)

• Timely completion of QC analysis as per defined TAT.

• Accuracy and compliance of analytical results and documentation.

• Reduction/minimization of laboratory errors and repeat analysis.

• Effective handling and timely closure of OOS/OOT and laboratory investigations.

• Compliance with GMP, SOP, safety, and data integrity requirements.

• Contribution towards laboratory improvement and cost optimization.Role & responsibilities

Preferred candidate profile

M. Pharma/equivalent qualification with relevant pharmaceutical QC experience.

Male Candidates are Preferred

Interested Candidates can contact

Aisha: [phone removed]