QA (Executive - Documentation)

2 weeks ago

Una, India Job Provider Baddi Full time

**Responsibilities:

- **

**Document Control Management**: Oversee the creation, revision, approval, distribution, and archiving of quality and manufacturing-related documents, including Standard Operating Procedures (SOPs), batch records, specifications, protocols, and reports.

**GMP Compliance**: Ensure that all documentation processes align with Good Manufacturing Practices (GMP) and other relevant quality regulations and standards, such as Good Documentation Practices (GDP).

**Quality System Support**: Assist in the implementation and maintenance of the Quality Management System (QMS), supporting quality processes, including change control, deviations, CAPAs, and risk assessments.

**Batch Record Review**: Review and approve batch records to verify that products are manufactured according to established procedures and meet the required quality specifications.

**Regulatory Compliance**: Collaborate with regulatory affairs and other departments to ensure that all documentation and processes comply with local and international regulatory requirements.

**Quality Audits and Inspections**: Prepare for and participate in internal and external quality audits and regulatory inspections, addressing any documentation-related findings and implementing corrective actions.

**Training and Compliance**: Conduct training for relevant personnel on documentation practices, data integrity, and quality-related topics to maintain a culture of compliance.

**Data Integrity**: Implement and monitor data integrity controls to ensure the accuracy, completeness, and reliability of documentation and records.

**Continuous Improvement**: Identify opportunities for process improvements related to documentation and data management to enhance efficiency and maintain compliance.

**Validation and Qualification**: Support the validation and qualification of equipment, processes, and computer systems to ensure they meet regulatory requirements.

**Archiving and Record Keeping**: Establish and maintain a secure and organized document archiving system for easy retrieval and compliance with record retention policies.

**Qualifications and Skills**:

- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field.
- Previous experience in a pharmaceutical quality assurance or documentation role is preferred.
- Knowledge of pharmaceutical regulations and guidelines, such as GMP, GDP, and data integrity requirements.
- management software is advantageous.
- Strong attention to detail and organizational skills to manage multiple documents and processes effectively.
- Excellent communication and interpersonal skills for collaborating with cross-functional teams.
- Problem-solving abilities and the capacity to implement practical solutions to quality and documentation challenges.

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

**Salary**: ₹240,000.00 - ₹300,000.00 per year

**Benefits**:

- Food provided
- Health insurance
- Paid sick time
- Paid time off
- Provident Fund

Schedule:

- Rotational shift

Supplemental pay types:

- Performance bonus
- Yearly bonus

Ability to commute/relocate:

- Una, Himachal Pradesh: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 2 years (preferred)

**Speak with the employer**
+91 9816576600

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