03 Aug
|
Weekday AI
|
Maharashtra
03 Aug
Weekday AI
Maharashtra
This role is for one of the Weekday's clients
Salary range: Rs ****** - Rs ******* (ie INR 9-10 LPA)
Min Experience: 6 years
Location: Pune
JobType : full-time
We are seeking an experienced and detail-oriented
Quality Control Executive
with a strong background in microbiology and pharmaceutical quality practices. The ideal candidate will have hands-on expertise in microbiological testing, culture preservation, microscopic analysis, and adherence to Good Manufacturing Practices (GMP) and GxP standards. This role requires an individual with proven skills in media preparation and consumption monitoring, as well as a comprehensive understanding of regulatory compliance in a fast-paced manufacturing setting. The candidate will play a pivotal role in ensuring product safety, quality, and compliance with both internal and external regulatory requirements.
Key Responsibilities
Conduct microbiological quality control testing including
microscopic count, microbial limit tests, and sterility assessments
to ensure product quality.
Perform and oversee
culture preservation techniques
to maintain reference strains and ensure availability of reliable microbial cultures for routine testing.
Ensure
accurate preparation, validation, and utilization of culture media
, including monitoring of media consumption and ensuring compliance with laboratory inventory requirements.
Implement and strictly adhere to
GMP, GxP, and other regulatory guidelines
, ensuring that all microbiological activities are conducted in compliance with international standards.
Maintain detailed documentation of laboratory results, standard operating procedures (SOPs), and quality control records in alignment with audit and regulatory expectations.
Assist in
method development and validation
for microbiological testing procedures, ensuring robustness and reproducibility.
Ensure
calibration, qualification, and routine maintenance of laboratory equipment
, including microscopes, autoclaves, incubators,
and microbial detection systems.
Train and mentor junior QC staff in best practices related to microbiological testing, documentation, and compliance.
Actively participate in
internal and external audits
, regulatory inspections, and continuous improvement initiatives to enhance laboratory performance and compliance.
Collaborate cross-functionally with production, R&D;, and quality assurance teams to address microbiological quality issues, deviations, or out-of-specification results.
Monitor and analyze laboratory data, preparing reports and presenting findings to management for decision-making.
Drive continuous improvement in QC processes, ensuring
accuracy, efficiency, and cost-effectiveness
in microbiological operations.
Required Skills & Competencies
Strong knowledge and hands-on experience in
quality control microbiology
.
Expertise in
microscopic count methods
and related microbial analysis techniques.
Proficiency in
culture preservation techniques
for long-term microbial strain stability.
In-depth knowledge of
GMP, GxP, and regulatory requirements
relevant to pharmaceutical/biotechnology industries.
Skilled in
media preparation and media consumption tracking
, with ability to optimize utilization.
Strong documentation and reporting skills, with attention to detail and compliance orientation.
Ability to troubleshoot laboratory issues and propose corrective and preventive actions (CAPAs).
Strong communication, leadership, and training abilities to guide junior staff and ensure team alignment.
Familiarity with laboratory information management systems (LIMS) and electronic documentation is preferred.
Qualifications
Master's degree in Microbiology, Biotechnology, or related life sciences discipline.
6–8 years of proven experience in
quality control microbiology
within pharmaceutical, biotechnology, or related industries.
Demonstrated track record of working in compliance with international standards such as
USFDA, EMA, or WHO GMP guidelines
.
📌 Quality Control Executive (Maharashtra)
🏢 Weekday AI
📍 Maharashtra