Job Title: Assistant Manager – Quality Control
Job Summary:
* Role: Assistant Manager, Quality Control
* Qualification: M.Sc.
* Experience Required: 0 to 5 years
* Core Focus: Analytical documentation review, laboratory compliance, instrument calibration, and Quality Management System (QMS) oversight.
* Key Objective: Ensuring all analytical data and laboratory operations adhere to stringent regulatory standards and internal specifications.
Job Overview:
We are currently seeking a detail-oriented and experienced professional to join our Quality Control department as an Assistant Manager. This role is pivotal in maintaining the integrity of our analytical processes and ensuring that all laboratory documentation is accurate, compliant, and completed within established timelines. The ideal candidate will possess a strong technical background in analytical chemistry and a thorough understanding of current Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
Key Responsibilities:
The Assistant Manager will be responsible for a wide range of oversight activities designed to uphold the highest quality standards. Your primary duties will include:
Documentation and Analytical Review:
You will be responsible for the comprehensive review of analytical documents covering in-process samples, water samples, raw materials, packing materials, intermediates, and finished products. This includes reviewing data related to stability studies, holding time studies, forced degradation studies, and working/reference standards. You will ensure that all analytical results are verified against pre-defined specifications and Standard Operating Procedures (SOPs).
Laboratory Equipment and Instrument Oversight:
A significant portion of this role involves the management of laboratory hardware. You will ensure that all measuring and testing instruments, particularly those related to HPLC, GC, and standalone instruments, are calibrated according to the established schedule. This includes verifying instrument status labels and boards, reviewing calibration data, and overseeing preventive maintenance reports to ensure operational readiness at all times.
Quality Management System (QMS) and Compliance:
You will play an active role in managing QMS activities. This involves investigating incidents, Out of Specification (OOS) results, Out of Trend (OOT) data, and Out of Calibration (OOC) findings. You will be tasked with identifying the root cause of deviations and ensuring that Corrective and Preventive Actions (CAPA) are implemented across the laboratory. Your work will ensure that we maintain strict adherence to GLP, GDP, and cGMP practices.
Operational Documentation and Data Integrity:
The Assistant Manager will review audit trails for both chromatographic and non-chromatographic systems to ensure data integrity. You will be responsible for handling various logbooks, including instrument and product-related logs, as well as column logs. Additionally, you will prepare and review critical quality documents and records, ensuring all inward documentation and observation data sheets are accurate and updated.
Process Coordination:
You will oversee the review of sampling activities and manage specific SAP-related tasks. It is essential that you coordinate effectively to ensure the timely release of intermediates and finished products. You will act as a point of contact for the review of protocols, raw data, and analytical reports, providing guidance to team members to ensure all laboratory operations run smoothly.
Required Qualifications and Skills:
* Educational Background: Candidates must possess an M.Sc. degree in a relevant scientific discipline.
* Experience: We are seeking candidates with 0 to 5 years of relevant experience in a Quality Control laboratory environment within the pharmaceutical or chemical industry.
* Technical Proficiency: Hands-on experience with LIMS (Laboratory Information Management System) and a solid understanding of analytical instrumentation such as HPLC and GC are mandatory.
* Analytical Skills: The ability to meticulously review raw data and identify inconsistencies is critical for this role.
* Compliance Knowledge: A deep-seated knowledge of cGMP, GLP, and GDP is essential. You must have a clear understanding of regulatory requirements and internal quality protocols.
* Communication and Leadership: As an Assistant Manager, you will demonstrate professional communication skills, the ability to work under pressure, and the capacity to mentor or guide junior staff when required.
Why Join Us:
Joining our team offers the opportunity to work in a fast-paced environment where quality is the foundation of every product we manufacture. We value accuracy, integrity, and a proactive approach to problem-solving. This position provides the right candidate with the opportunity to grow their career within a structured quality environment and contribute significantly to our commitment to excellence.
Application Process:
If you meet the requirements and are passionate about maintaining high-quality standards in pharmaceutical manufacturing, we encourage you to apply. Please ensure your resume highlights your specific experience with analytical instrumentation, laboratory documentation review, and your familiarity with QMS processes.
We look forward to receiving your application and discussing how your skills can contribute to our team’s success.