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Leben Life Sciences Pvt. Ltd. Opens Exciting Career Opportunities in Quality Assurance
Akhila Today – Leben Life Sciences Pvt. Ltd. (LLS), a respected pharmaceutical formulation company with over four decades of industry experience, is actively recruiting talented professionals for its state-of-the-art EU-GMP Approved Global Standard OSD & Semi-solids Formulation manufacturing facility located in Akola, Maharashtra.
About the Company
With a legacy spanning forty years, Leben Life Sciences has established itself as a trusted and reliable name in the pharmaceutical sector. The company is deeply committed to maintaining the highest standards of quality, innovation, and compliance, operating under the guiding principle of “Responsible Healthcare.” Their advanced, EU-GMP approved manufacturing facility in Akola is a testament to their dedication to meeting rigorous international standards and delivering excellence to the global market.
Current Job Openings in Quality Assurance
Leben Life Sciences is seeking dedicated and skilled professionals to join their Quality Assurance Department, a critical function for ensuring product safety and efficacy. The company is offering two key positions for male candidates:
Senior Officer – Documentation
Area of Work: Documentation
Qualification: B.Pharm / M.Pharm / M.Sc
Experience: 2 to 4 years
Officer – AQA (Analytical Quality Assurance)
Area of Work: AQA
Qualification: B.Pharm / M.Pharm / M.Sc
Experience: 2+ years
Why Join Leben Life Sciences?
A career with LLS offers more than just a job; it is an opportunity to become part of a legacy of pharmaceutical excellence. Employees benefit from:
· Working in a globally compliant, EU-GMP approved facility.
· Gaining exposure to advanced manufacturing processes for Oral Solid Dosage (OSD) and Semi-solids.
· Being part of a stable, four-decade-old organization with a strong industry reputation.
· Contributing to the mission of “Responsible Healthcare,” ensuring that patients receive high-quality medicines.
How to Apply?
Interested and eligible male candidates are encouraged to seize this opportunity to advance their careers. Please submit your updated resume via email.
Email: career@lebenlifesciences.com
Contact Number: 7498035480
This is an excellent opportunity for quality assurance professionals to grow with a company that values expertise, precision, and a commitment to global health standards.
FAQ:
1. What are the key elements of a Good Documentation Practice (GDP) in the pharmaceutical industry?
Answer:
Good Documentation Practices (GDP) ensure data integrity, traceability, and compliance. The key elements include:
Legibility, accuracy, and completeness of records.
Real-time documentation (no backdating).
Authorized corrections with signature and date.
Controlled document management with version control.
Compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).
2. What is the role of Analytical Quality Assurance (AQA) in a pharmaceutical company?
Answer:
AQA ensures analytical data integrity and reliability. Responsibilities include:
Review and approval of analytical documents (specifications, methods, and validation reports).
Monitoring laboratory compliance with cGMP and GLP standards.
Oversight of instrument qualification and calibration.
Ensuring adherence to SOPs during testing and documentation.
Conducting audits of analytical laboratories and data review.
3. What are the key differences between OOS (Out of Specification) and OOT (Out of Trend) results?
Answer:
OOS (Out of Specification): Test results fall outside predefined acceptance criteria or specifications.
OOT (Out of Trend): Test results are within specification limits but deviate significantly from historical data or established trends.
Action: OOS requires a formal investigation, while OOT needs trend analysis and potential preventive action.
4. Explain the process of change control in Quality Assurance.
Answer:
Change control is a formal process for managing modifications to systems, equipment, or processes.
Steps include:
Initiation of change request with justification.
Impact assessment (on product quality, validation, and documentation).
QA review and approval.
Implementation and validation.
Closure after verification of effectiveness.
5. What are the key parameters checked during line clearance in production or packaging areas?
Answer:
Before starting any new batch, QA performs line clearance to prevent mix-ups or contamination. Key checks include:
Cleanliness of area, equipment, and utensils.
Removal of previous product labels, documents, and materials.
Verification of correct batch documents and materials.
Equipment calibration and status labeling.
QA authorization to proceed with batch manufacturing.
