Gufic Biosciences Sr. Executive / Executive – QA (PV Profile)
Gufic Biosciences Limited is hiring a Sr. Executive / Executive – QA (PV Profile) for its Indore Plant / Pithampur location.
The position is suitable for experienced pharmaceutical QA professionals with 6–10 years of experience, particularly from an injectable formulation background.
The role covers Annual Product Quality Review, deviations, CAPA, change controls, process validation, bulk hold-time studies, market complaints, and regulatory documentation.
Candidates with B.Pharm or M.Pharm qualifications and relevant Pharmaceutical Quality Assurance experience can apply.
Sr. Executive / Executive – QA (PV Profile)
Job Role & Responsibilities
The selected candidate will be responsible for the following Quality Assurance activities:
- Prepare and execute Annual Product Quality Review (APQR).
- Initiate and manage:
- Change Control
- Deviation
- Non-Conformance Report
- Corrective and Preventive Action (CAPA)
- Incident
- Out of Specification (OOS)
- Out of Trend (OOT)
- Market Complaint Investigation
- Prepare process validation and bulk hold-time study protocols and reports.
- Execute and compile process validation and bulk hold-time studies according to approved protocols.
- Handle visual inspector qualification activities.
- Prepare and review Standard Operating Procedures (SOPs).
- Maintain documentation according to current Good Manufacturing Practices (GMP).
- Provide required documents to the Regulatory Affairs department.
- Coordinate with internal and external department personnel.
- Maintain and track the status of:
- Process Validation
- Product Bulk Hold-Time Studies
Eligibility & Qualifications
Educational Qualification
B.Pharm in Any Specialization
M.Pharm in Any Specialization
Experience
6–10 years of experience
The desired candidate profile specifies experience from a Pharma – Injectable Formulation background.
Eligible Qualification Courses
B.Pharm | M.Pharm
Desired Candidate Profile
Candidates should:
- Come from a Pharma – Injectable Formulation background.
- Have knowledge of the regulatory market.
- Be willing to work at Pithampur, near Indore, Madhya Pradesh.
Required QA Skills
The job posting highlights the following areas:
- Quality Assurance
- Process Validation
- Sterile Manufacturing
- Pharmaceutical Injectables
- Annual Product Quality Review
- Change Control
- Deviation Management
- CAPA
- Non-Conformance
- Incident Management
- OOS
- OOT
- Market Complaint Investigation
- Bulk Hold-Time Studies
- SOP Preparation and Review
- GMP Documentation
- Regulatory Documentation
- Visual Inspector Qualification
- USFDA
- 21 CFR
Job Location & Details
Company: Gufic Biosciences Limited
Position: Sr. Executive / Executive – QA (PV Profile)
Plant: Indore Plant
Work Location: Pithampur, near Indore, Madhya Pradesh
Experience: 6–10 years
Vacancies: 1
Salary: ₹5–8 LPA
Employment Type: Full Time, Permanent
Department: Quality Assurance
Industry: Pharmaceutical & Life Sciences
How to Apply
Interested and eligible candidates can send their updated CV to:
Email: recruitment.indore@guficbio.com
Candidates should have relevant experience in Pharmaceutical Injectable Formulations and Quality Assurance.
Job Summary
| Category | Details |
|---|---|
| Company | Gufic Biosciences Limited |
| Vacancies | Sr. Executive / Executive – QA (PV Profile) – 1 Position |
| Required Education | B.Pharm in Any Specialization, M.Pharm in Any Specialization |
| Experience | 6–10 years |