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Engaged Employer

Global Calcium

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3.9

based on 281 Reviews

1 Global Calcium Assistant Manager Quality Control Job

Assistant Manager - Quality Control (API)

Global Calcium Pvt. Ltd

3.9

based on 281 Reviews

8-12 years

₹ 5.8 - 9.25L/yr (AmbitionBox estimate)

Hosur

1 vacancy

Assistant Manager - Quality Control (API)

Global Calcium

posted 3mon ago

Job Role Insights

Flexible timing

Key skills for the job

Analytical Chemistry Compliance HPLC GMP Spectroscopy GLP

+ 1 more

Job Description

Analytical Method Validation:
Validate and verify analytical methods for both APIs and finished pharmaceutical products to ensure accuracy, reliability, and compliance with industry standards.
Stability Protocols Review:
Review and approve stability protocols to monitor the integrity of API and finished products throughout their shelf life. Ensure all stability studies are conducted in accordance with regulatory requirements and follow up on stability study activities.
SOP Development and Maintenance:
Develop, implement, and maintain Standard Operating Procedures (SOPs) and standard testing procedures for quality control processes, ensuring alignment with best practices and regulatory guidelines.
Out-of-Specification (OOS) Investigations:
Conduct thorough investigations for any OOS results, identify root causes, implement corrective actions, and ensure appropriate documentation of all findings.
Issuance Control of Hazardous and Poisonous Chemicals:
Oversee the issuance control and safe handling of hazardous and poisonous chemicals, ensuring compliance with safety regulations and providing adequate training to QC personnel.
Volumetric Solution Standardization:
Oversee the standardization of volumetric solutions and the management of chemical inventory, ensuring compliance with safety and quality protocols.
Facility Provision and Implementation:
Ensure all QC personnel have access to adequate facilities and resources, implementing improvements in line with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) guidelines.
CAPEX Requests Preparation:
Prepare and justify Capital Expenditure (CAPEX) requests for laboratory equipment, ensuring that all purchases align with departmental needs and budget constraints.

Qualifications:

Education:
Master s degree or PhD in Chemistry, Pharmaceutical Sciences, or a related field from a recognized institution.
Experience:
8-12 years of demonstrated experience in Quality Control within the pharmaceutical industry, specifically with Active Pharmaceutical Ingredients (API).
Technical Skills:
Proficient in various analytical techniques (e.g., HPLC, GC, UV-Vis spectroscopy) and knowledgeable about regulatory standards (e.g., ICH, FDA, EMA).
Regulatory Knowledge:
Familiarity with Good Manufacturing Practices (GMP) and Quality Assurance (QA) principles.
Analytical Thinking:
Strong analytical and problem-solving skills, with a keen attention to detail.
Leadership:
Proven ability to lead teams and manage projects effectively, ensuring timely completion of quality control objectives.