Assistant Manager- Quality Control, Chemistry

Zentiva; Ankleshwar; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Zentiva in Ankleshwar, India invites an Assistant Manager-Quality Control, Chemistry to lead QC activities ensuring GMP/GLP compliance and robust documentation. You will drive testing of finished goods, raw materials and stability samples, oversee calibration and LIMS management, and contribute to SOPs and regulatory reporting.

The role requires 8–10 years in a chemical testing lab, strong leadership, analytical skills, and the ability to train subordinates in quality and safety systems.

Qualifications

• Post Graduate in Science (Organic or Analytical Chemistry) with 8–10 years in chemical & instrumental testing laboratory with exposure to GMP/GLP.
• Technical competence and leadership required.
• Experience with calibration, documentation, SOPs and pharmacopeia review.
• Knowledge of ISO 14000 and regulatory compliance.

Responsibilities

• Perform and organize timely analysis of finished goods, raw materials, intermediate and other samples for Chemistry.
• Analyze market complaints, stability, process validation, cleaning validation samples.
• Calibrate and maintain lab equipment; assist qualification of laboratory equipment.
• Review pharmacopeias for specification preparation; prepare SOPs, formats, specifications and analytical test records.
• Manage reference standards, working standards, laboratory chemicals & reagents; oversee LIMS and data.
• Approve/reject raw materials, packaging materials, in-process materials, bulk finished products and bulk medical devices; investigate OOS results.
• Ensure compliance with GMP, ALCOA+ practices; participate in regulatory inspections; training of subordinates on quality and HSE systems.

Skills

Technical competence

Leadership

Analytical ability

Planning ability

Communication skills

Problem solving

Education

Postgraduate in Science (Organic or Analytical Chemistry)

Tools

LIMS

HPLC

Job description

JOB TITLE Assistant Manager- Quality Control, Chemistry

REQUIREMENTS

Education / Experience Post Graduate in Science (Organic or Analytical Chemistry ) 8 to 10 years in chemical & instrumental testing laboratory with exposure to GMP, GLP.

Technical skills &

Competencies / Language · Technical competence · Leadership skills · Analytical ability · Planning ability · Communication skills · Problem solving

JOB PURPOSE

Generic To perform QC activities in order to ensure quality of products and services and maintain related documentation to adhere to Quality operations and regulatory requirements. All above activity shall be done living Group’s Values and Code of Ethics.

KEY ACCOUNTABILITIES

Testing

1.1. Performing and organizing timely analysis of finished goods, stability samples, raw material, intermediate

and other samples for Chemistry.

1.2. Performing and organizing analysis of market complaints, Stability, process validation, Cleaning

Validation samples.

Good Laboratory Practice

2.1. Performing and organizing calibration / maintenance of lab. Equipment and assisting for the qualification

of laboratory equipment.

2.2. Reviewing pharmacopeias for specification preparation.

2.3. Preparing SOPs, Formats, Specification, Analytical Test Record and other documents.

2.4. Managing reference standards, working standards, Laboratory chemicals & reagents.

2.5. Managing instrument laboratory with reference to spares, maintenance etc.

2.6. Managing Control Samples and related record.

2.7. Approval / Rejection of Raw Materials, Packaging materials, in process materials, Bulk Finished products

and bulk medical device.

2.8. Investigating out of specification results, retesting and review the analysis records.

2.9. Maintaining & reviewing laboratory raw data and log book related to testing activity.

2.10. Responsible for reviewing the chromatographic data.

2.11. Management of LIMS and static data

Quality, HSE and Compliance

3.1. Adhere to current GMP guidelines

3.2. Following ALCOA+++ practices during documentation and related activities 3.3. Compliance to local and international HSE norms

3.4. Regulatory compliance

3.5. ISO 14000 related activities

3.6. Regular Pharmacopoeia and regulatory requirement review for compliance 3.7. To participate in any regulatory/Customer inspection takes place at the site 3.8. Training of self and subordinates on quality and HSE systems

Validation

4.1. Preparing protocol and report for Analytical Method validation, cleaning validation and performing / organizing the validation exercise as per the protocol. 5. Management of laboratory Consumables

5.1. Identifying and planning requirement for laboratory consumables and monitoring the stock of chemical, glassware and printed material.

5.2. Maintaining stock of laboratory chemicals in line with budget

Co ordination

6.1. Coordinating with production, and warehouse for analytical activities.

Other

7.1. Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.

7.2. Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.

7.3. Performing internal quality audit as a “Qualified Internal Auditor” during internal Quality Audit abiding the internal quality audit schedule.

7.4. Train the subordinate for laboratory related jobs.