Apex Laboratories Private Limited has announced an exciting recruitment opportunity for experienced pharmaceutical professionals in the Analytical Quality Assurance (AQA) and Quality Control (QC) departments. Candidates with experience in Oral Solid Dosage (OSD) formulation units and a strong understanding of pharmaceutical quality systems are encouraged to apply.
This hiring drive is ideal for professionals seeking career growth in a reputed pharmaceutical manufacturing organization known for its commitment to quality, compliance, and innovation.
Job Overview
Details
Company Name
Apex Laboratories Private Limited
Department
AQA & QC
Experience
2–4 Years
Qualification
B.Pharm / M.Sc Chemistry
Industry
Pharmaceutical Manufacturing
Location
Alathur, Chengalpattu District, Tamil Nadu
Joining
Immediate Joiners Preferred
Key Responsibilities
Analytical Quality Assurance (AQA)
Review analytical method validation and verification reports.
Ensure compliance with cGMP, GLP, and regulatory guidelines.
Monitor laboratory documentation and data integrity practices.
Support audit preparation and regulatory inspections.
Review analytical investigations and OOS/OOT reports.
Quality Control (QC)
Perform analysis of raw materials, in-process samples, and finished products.
Operate analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, and Dissolution Apparatus.
Maintain laboratory records according to GMP requirements.
Conduct stability sample testing and environmental monitoring activities.
Ensure timely completion of testing activities and documentation.
Required Qualifications
Candidates should possess:
B.Pharm or M.Sc in Chemistry.
2 to 4 years of experience in OSD formulation manufacturing.
Knowledge of pharmaceutical quality systems.
Hands-on experience with analytical instruments.
Understanding of regulatory requirements and data integrity principles.
Why Join Apex Laboratories?
Apex Laboratories offers a professional work environment that emphasizes:
Career growth and skill development.
Exposure to advanced analytical technologies.
Strong quality-focused culture.
Regulatory-compliant manufacturing practices.
Opportunities to work with experienced pharmaceutical professionals.
Application Details
Email: srinivasan.hr@apexlab.com
Contact Numbers:
7373296905
9597168805
Company Address:
Apex Laboratories Private Limited
MHRA – Plant II
C-6, C-7 & A-8 SIDCO Pharmaceutical Complex
Alathur, Chengalpattu District
Tamil Nadu – 603110
Applicants are advised to carry an updated resume and relevant educational and experience certificates.
Technical FAQs
1. What analytical instruments are commonly used in QC laboratories for OSD products?
QC laboratories typically use HPLC, GC, UV-Visible Spectrophotometers, Dissolution Test Apparatus, FTIR, and Karl Fischer Titrators for testing raw materials, intermediates, and finished products according to approved specifications.
2. What is the difference between OOS and OOT results?
OOS (Out of Specification) results fall outside predefined acceptance criteria, whereas OOT (Out of Trend) results remain within specifications but show unexpected deviation from historical trends and require investigation.
3. Why is method validation important in pharmaceutical analysis?
Method validation demonstrates that an analytical method consistently produces accurate, precise, specific, robust, and reliable results suitable for its intended purpose, ensuring regulatory compliance.
4. What is data integrity in pharmaceutical quality systems?
Data integrity ensures that laboratory data is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available throughout its lifecycle, following ALCOA+ principles.
5. What are critical quality attributes (CQAs) in OSD formulations?
CQAs are physical, chemical, biological, or microbiological characteristics that must remain within specified limits to ensure product quality, safety, efficacy, and regulatory compliance. Examples include assay, dissolution, content uniformity, and impurity levels.
