Executive IPQA

Geltec Private Limited; Bengaluru; On-site; INR 700,000 - 900,000; Full time

Job summary

Geltec Private Limited is seeking an IPQA professional in Bengaluru to plan and execute the Quality Assurance plan with in-process checks and line clearances. The role requires 4–6 years in pharma and a strong grounding in GMP and documentation practices.

Key duties include releasing products, maintaining BMRs, and ensuring cGMP compliance while coordinating with QA to uphold quality standards for timely batch release.

Qualifications

• M.sc Biochemistry required.
• 4-6 years of experience in Pharmaceutical Industry.
• Graduation in science and good interpersonal skills.

Responsibilities

• Know products, SOPs, processes, systems and practices of the department.
• Issue and receive BMRs.
• Provide line clearance for Raw material store, Medicine, Encapsulation, Gelatin, Tablet dept., Powder processing, and Packing operations.
• Ensure materials dispensed per indents/BOM.
• Carry out in-process quality checks for multiple departments and ensure status labeling is updated.
• Ensure online documentation such as BMR and equipment/Area log books.
• Monitor calibration activity on the shop floor and environmental monitoring.
• Ensure cGMP compliance and good documentation practices on the shop floor.
• Review SOPs review date and ensure validity.
• Sample in-process and process validation samples; maintain cleanliness and approvals.
• Arrange gel mass and ensure gel mass color approval; perform finished goods AQL.

Skills

Interpersonal skills

Education

M.sc Biochemistry

Job description

JOB DESCRIPTION IPQA

1. JOB PURPOSE:

To Plan and execute Quality Assurance plan by carrying out in-process quality assurance checks.

2. KEY RESULT AREA:

a. Monitoring of Quality Assurance Plan: - To learn and execute quality assurance plan – carry out in-process quality assurance checks and providing line clearance in order to ensure timely release of Products to the next stage of production processing maintain delivery schedule of the company's market requirement.

b. Documentation: - Timely completion of documents for release of products as per scheduled delivery.

c. GMP and Quality Compliance: - To implement and follow quality and GMP / GLP compliances in the area of responsibility, report deviations and non-compliances in order to ensure delivery of high-quality products to avoid market complaints and audit observations.

d. Liaison and Networking: - To liaise with Executive – QA for any additional work such as improving quality standards and avoid any non-compliances.

3. KNOWLEDGE / EXPERIENCE / SKILLS REQUIRED:

e. KNOWLEDGE: M.sc Biochemistry

f. EXPERIENCE: 4-6 years of experience in Pharmaceutical Industry.

g. SKILLS: Graduation in science and good interpersonal skills.

4. PRIMARY RESPONSIBILITIES:

• To have knowledge of products, SOPs, processes, systems and practices related to the department functions.
• To Issue and receive BMRs.
• Providing line clearance for Raw material store, Medicine, Encapsulation, Gelatin, Tablet dept. Powder processing area & Packing dept. operations.
• Ensure that Materials dispensed as per indents/BOM.
• To carry out in-process quality assurances checks for Raw material store, Medicine, Encapsulation, Gelatin, Tablet dept, Powder processing area & Packing dept. operations.
• Ensure that status Labeling is updated.
• To ensure online documentation such as BMR and equipment or Area log books.
• Monitoring calibration activity in shop floor.
• Ensuring environmental monitoring in the shop floor.
• Ensuring cGMP compliance in the shop floor.
• Ensuring Good documentation practices.
• Ensuring SOPs review date with in validity.
• Sampling of in process and process validation samples.
• Ensuring the preparation of gel mass and maintenance of cleanliness.
• Gel mass color approval.
• Releasing of intermediate batch for next stage by doing AQL.
• Ensure GMP compliances in respect of sanitation, dress code, wearing of jewellery, prevention of hairs, nail polish etc.
• Ensure proper door culture.
• Co-ordination for internal and external audit.
• Reporting the deviations to supervisor.
• To review and reconcile BMRs and other documents and maintain records.
• Ensure batch records are submitted in time to QA and on time batch release.
• To carry out APQR related work on need basis.
• Approve stereos for over printing.
• Issues, reconciliation, and destruction stereos.
• Maintain appropriate status labeling in BSR.
• To arrange ADC sample and COA's to Head office need basis.
• To perform finished goods AQL.
• From Post production dept. Bulk issuance for packing and Bulk AQL.
• Handling of control sample maintenance.
• To carry out any additional responsibilities given by section in charge QA and Head- QA.

5. DECISION MAKING AUTHORITY AND CONTROL:

Not Applicable

6. PROBLEMS / KEY FEATURES:

Not Applicable

7. HISTORY OF REVISION:

Reporting to changed from Asst.Manager to section in charge

8. In absence, his/ her duties shall be performed by other Executive QA/Sr .Executive.