CAREERS

DEPARTMENT: QUALITY ASSURANCE

Key Responsibilities

1. Ensure that cGMP is adhered to in all areas of the facility

2. Assemble and review all documentation related to the processing, packing and testing of each batch of the product before authorizing for dispatch from manufacturing

3. Generate, approve and issue Batch Documents

4. Ensure that appropriate calibration and preventive maintenance of the manufacturing equipment is conducted as scheduled

5. Ensure continuous review and upgrading of existing SOPs and work systems with respect to current guidelines

6. Ensure area cleaning and line clearance during product change over, and other controls related to manufacturing, packing and stores equipment / machines /area

7. Responsible for the review, approval and obsoleting master batch documents

8. Perform and monitor in process checks during manufacturing and packing

9. Support validation team during process, pack-line and cleaning and ensure proper documentation of the same

10. Perform Pack-line Inspection and Finished Product Sampling as per procedures

11. Review and monitor Pest control activities

12. Oversee the environmental monitoring program to ensure the manufacturing environment meets required standards 13. Participate in initiatives to improve quality systems, processes, and overall product quality

Qualifications

• Bachelor’s degree of Pharmacy, Industrial Chemistry, Pharmaceutical Science, or any other related course  2+ years’ experience within the Pharmaceutical Industry

• Proficiency in MS Office (Excel, PowerPoint presentations)

• High analytical mind, with exceptional problem-solving skills and attention to detail

• Ability to work independently and collaboratively in a team environment, and adherence to cGMP and Quality Management Systems.

• A self-starter, creative, innovative, flexible and able to work well under pressure at work  Excellent communication skills, both oral and written

• Able to work shifts on any day of the week whenever required

How to apply

Email your application, detailed CV and copies of academic certificates in a PDF file to; recruitment@qcil.com.

Deadline for receiving applications: Friday, 30th August 2024, at 5:00 pm.

Only short-listed candidates will be contacted. Qcil is an equal opportunity employer and therefore lobbying for the above position will lead to automatic disqualification.

DEPARTMENT: QUALITY ASSURANCE

 Key Responsibilities

1. Oversee the transfer and introduction of new or modified manufacturing processes into production.

2. Ensure that all aspects of the process, including equipment, raw materials, and procedures, are effectively translated into the production environment.

3. Prepare and review technology transfer documentation, including validation protocols, reports, and batch records

4. Maintain documentation to ensure traceability and compliance with regulatory requirements.

5. Act as a liaison between Quality Assurance (QA), Quality Control (QC), Production, Regulatory Affairs (RA) teams to ensure smooth communication and collaboration during the transfer process.

6. Analyse validation data and prepare reports to support the validation process.

7. Identify and resolve issues that arise during the transfer or scale-up of manufacturing processes.

8. Work with manufacturing teams to optimize processes for efficiency, output, and product quality

9. Ensure that all technology transfer activities comply with Good Manufacturing Practices (GMP), regulatory guidelines, and company policies.

10. Prepare necessary documentation for submission to regulatory authorities as required.

11. Track project timelines and milestones to ensure that transfer activities are completed on schedule.

12. Conduct risk assessments related to the transfer of processes or technologies to identify potential challenges or risks.

Qualifications

• Bachelor’s degree of Pharmacy.

•  2+ years’ experience within the Pharmaceutical Industry.   Proficiency in MS Office (Excel, PowerPoint presentations)

•  High analytical mind, with exceptional problem-solving skills and attention to detail.

• Ability to work independently and collaboratively in a team environment, and adherence to cGMP and Quality Management Systems.

•  A self-starter, creative, innovative, flexible and able to work well under pressure at work.  Excellent communication skills, both oral and written.

How to apply

Email your application, detailed CV and copies of academic certificates in a PDF file to; recruitment@qcil.com.

Deadline for receiving applications: Friday, 30th August 2024, at 5:00 pm.

Only short-listed candidates will be contacted. Qcil is an equal opportunity employer and therefore lobbying for the above position will lead to automatic disqualification. Qcil is an equal opportunity employer and therefore lobbying for the above position will lead to automatic disqualification.