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3 BIOALTUS PHARMACEUTICALS Jobs
Head/ Manager/ Senior Executive -QA-QC
3-8 years
Vapi, Valsad
1 vacancy
Head/ Manager/ Senior Executive -QA-QC
BIOALTUS PHARMACEUTICALS
posted 10hr ago
Job Description
- Quality Systems and SOPs:
- Prepare, review, and provide training on departmental Standard Operating Procedures (SOPs). Develop and implement quality systems, policies, and guidelines to meet cGMP and regulatory requirements. Conduct Quality Systems training and compliance-related training for the QA team and other relevant departments.Ensure adherence to Good Documentation Practices (GDP) across all documentation activities.
- Document Control and Compliance:
- Review and approve quality management documents such as change controls, deviations, User Requirement Specifications (URS), SOPs, and Quality Risk Management (QRM) documents. Manage the preparation, issuance, revision, archival, distribution, and retrieval of documents such as logbooks and other controlled forms. Maintain document control for issued and master documents, ensuring proper version control and accessibility.
- Coordination with Cross-functional Teams:
- Coordinate with various departments, including Research & Development (R&D) and production, to ensure overall compliance and to achieve organizational goals. Work closely with project leaders to support the successful completion of projects.
- Technology Transfer:
- Oversee technology transfer activities, including preparing required documents, reviewing relevant reports, and collaborating with the R&D team during lab and pilot plant activities.
- Validation and Qualification:
- Review method validation protocols and reports, stability studies, and analytical methods. Review and monitor qualification documents (IQ, OQ, PQ) for equipment and processes, ensuring alignment with regulatory and internal standards. Ensure calibration and preventive maintenance schedules are followed.
- Regulatory Compliance and Licensing Support:
- Ensure all activities are conducted in compliance with established safety standards, SOPs, and regulatory requirements.
- Create, update, and Review, Bills of Materials for various products.
Employment Type: Full Time, Permanent
Read full job description What people at BIOALTUS PHARMACEUTICALS are saying
Senior Executive salary at BIOALTUS PHARMACEUTICALS
reported by
1
employee
with 10
years exp.
₹5.6
L/yr - ₹7.1
L/yr
15%
more
than the average Senior Executive Salary in India
View more details
What BIOALTUS PHARMACEUTICALS employees are saying about work life
based on 14 employees
Flexible timing
Monday to Saturday
Within city
Day Shift
BIOALTUS PHARMACEUTICALS Benefits
View more benefits
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