Pharma Quality Control Officer

2 days ago

Ahmedabad Gujarat, India Swiftmed International Private Limited Full time

**Position Overview**:
We are looking for a dedicated and detail-oriented **QC Officer** to join our **office-based Quality Control team**. This role is focused on **documentation, review, and coordination activities**, without involvement in laboratory testing. The QC Officer will play a key role in maintaining the integrity of quality systems and supporting regulatory and quality assurance functions.

**Key Responsibilities**:

- **Document Review & Preparation**:

- Prepare and review key quality documents such as:

- ST/MoA (Specifications and Methods of Analysis)
- AMV (Analytical Method Validation documents)
- Finished Product Specifications
- Certificate of Analysis (CoA)
- Stability protocols and reports
- Other documents
- **Validation Support**:

- Draft and review validation protocols and reports in alignment with applicable guidelines and internal SOPs.
- **Quality Standards Oversight**:

- Establish and review specifications for finished products and APIs in accordance with regulatory and internal quality standards.
- **Regulatory Support**:

- Assist the Regulatory Affairs team with documentation for submissions, audits, and query responses.
- **Quality System Awareness**:

- CAPA (Corrective and Preventive Actions)
- Change Control
- Deviation handling and documentation
- **Audit Participation**:

- Support internal and external audits (regulatory or customer) through documentation readiness and audit coordination.
- **Cross-functional Support**:

- Provide assistance on any quality-related assignments or projects as directed by QC leadership.

**Qualifications & Skills**:

- **Education**: Bachelor's or Master’s degree in Pharmacy, Chemistry, or related field.
- **Experience**: 2-5 years in a QC documentation or compliance role within the pharmaceutical or healthcare industry.
- **Skills Required**:

- Strong understanding of GMP, ICH, and regulatory requirements
- Proficient in preparing and reviewing quality documents
- Knowledge of QA concepts such as CAPA and audit management
- Excellent organizational and communication skills
- Attention to detail and commitment to compliance

**Work Environment**:

- This is a **non-laboratory, office-based position**.
- Collaboration with QA, Regulatory Affairs, and other departments is essential.
- Some participation in plant visits or audits may be required, but routine lab work is **not part of this role**.

**Job Types**: Full-time, Permanent

Pay: ₹20,000.00 - ₹35,000.00 per month

Schedule:

- Day shift

Ability to commute/relocate:

- Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelor's (required)

**Experience**:

- Quality control: 2 years (required)
- Pharmaceutical manufacturing : 1 year (preferred)

Willingness to travel:

- 25% (preferred)

Work Location: In person

Application Deadline: 18/07/2025

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