Quality Assurance Job Vacancy at Alkem Laboratories

 Alkem Laboratories Hiring Officer – Quality Assurance

Alkem Laboratories, a global leader in the pharmaceutical industry, is looking for experienced professionals for the role of Officer – Quality Assurance. If you have 2-5 years of experience in IPQA, GMP, audit trails, and electronic documentation, this is your chance to work with one of India’s top pharma companies.

Alkem Laboratories Founded in 1973, Alkem Laboratories is among India’s leading pharmaceutical companies, with a presence in over 40 countries and a portfolio of 800+ brands. With 19 manufacturing facilities and 5 R&D centers, Alkem fosters innovation and career growth for over 21,000 professionals.

Alkem Laboratories Job Details

Position: Officer / Sr. Officer – Quality Assurance

Required Experience: 02 – 5 Years

Key Responsibilities:

• Perform sampling procedures, including blend uniformity and stratified sampling.
• Ensure compliance with GMP guidelines and regulatory standards.
• Conduct audit trails for equipment and software.
• Oversee calibration, in-process checks, and shop floor monitoring.
• Investigate and document failures and deviations occurring on the shop floor.
• Maintain electronic documentation and data integrity in compliance with company policies.

Required Qualifications:

B Pharm, M.Pharm, BSc, MSc in Life Sciences, Chemistry, or a related field.

Skills Required:

 QUALITY COMPLIANCE AND SYSTEM:

Documentation

• To ensure online documentation related to current good manufacturing practices (cGMP).
• Continuous improvement and review for upgrading existing SOP’s with respect to compliance to global standards.

Quality Management System

• Ensure the compliance of existing SOP’s related to Equipment Qualification, area qualification, HVAC revalidation, temperature mapping, SMF, VMP etc.
• Ensure that change controls are appropriately evaluated as per change control procedure.
• Ensure that deviation is evaluated as per deviation procedure.
• Ensure that CAPA are evaluated as per CAPA procedure.
• Ensuring and practicing Good Documentation practice in Department.
• Ensuring and Monitoring the GMP compliance in department

QUALITY OPERATIONS

Authorized to issue and control

• Validation / Qualification Protocol numbers.
• Room Identification numbers for all department.
• Equipment identification numbers for Production, Warehouse & Engineering equipment.

Authorized to review, approve and control of document

• Equipment Qualification document protocols and reports.
• Utilities Qualification protocols & reports.
• Area Qualification protocols & reports.
• Validation Master Plan and Project Plans.
• Site Master File.
• User requirement Specification.
• Standard Operating Procedures.
• Issue and control for Qualification/Validation/Miscellaneous protocol numbering, Equipment/Instrument/Utilities/Room/Area identification numbering.
• Prepare, review, issue, retrieve and control of documents like Equipment/ Utilities/Area/Instrument qualification protocol and report. Temperature mapping protocol and report.
• Prepare, review and issue Cleaning validation/Process validation/Cross contamination/ Hold Time study/Miscellaneous protocol and report.
• Review and approval of FAT protocols and its execution.
• Monitor, execute and compiled all qualification and validation related activities.
• Perform DEHT and CEHT study on worst case molecules.
• Communicate with R&D, Regulatory affairs and CQA related to qualification and validation related documents.
• Monitoring and review of calibration and engineering related activities.
• Monitoring and review of computer system /PLC validation related activities.
• Perform the activities allotted by section in charge.
• Impart the training related to GMP, qualification, validation, and guideline updated.
• Review APQR annexure for equipment and HVAC qualification details.
• Prepare and review risk assessment.
• Perform assigned activity from QMS tools like change control, CAPA, deviation etc.
• Initiate any QMS tools in Trackwise as per the need.

How to Apply?

Interested candidates can apply here:

🔗 Apply Now