Assistant Manager / Deputy Manager - QA

Why This Role Matters
Quality Assurance is the backbone of any pharmaceutical or biopharmaceutical organization. In a regulated industry where patient safety and compliance are paramount, this role ensures that products consistently meet established quality standards and regulatory expectations. As an Assistant Manager / Deputy Manager – QA, you will play a vital leadership role in safeguarding documentation integrity, managing investigations, and strengthening quality systems.
This position offers the opportunity to contribute directly to regulatory readiness, operational excellence, and continuous improvement initiatives within a growing biopharmaceutical organization. Your expertise will support compliance with global regulatory standards while driving a culture of quality across departments.

Job Description
Provis Biolabs is seeking an experienced Assistant Manager / Deputy Manager – Quality Assurance for its facility in Jadcherla, Hyderabad. The selected candidate will lead and manage critical QA functions, ensuring adherence to GMP guidelines, regulatory requirements, and internal quality systems.
This role is ideal for professionals with 7–10 years of hands-on QA experience in pharmaceutical or biopharmaceutical environments. The position requires strong leadership capabilities, in-depth compliance knowledge, and the ability to manage investigations, documentation, and cross-functional coordination effectively.

Key Features of the Role
• Mid-senior leadership position within Quality Assurance
• Exposure to pharmaceutical and biopharmaceutical manufacturing environments
• Active involvement in regulatory compliance and audit readiness
• Opportunity to lead deviation and CAPA management systems
• Strategic role in documentation control and data integrity assurance
• Cross-functional collaboration with Production, QC, and Regulatory teams
• Career growth within a developing biopharmaceutical organization

Responsibilities
• Review and approve Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and Batch Packaging Records (BPRs)
• Manage deviations, OOS, OOT investigations, and implement effective CAPA
• Conduct detailed root cause analysis using structured investigation tools
• Oversee document lifecycle management ensuring compliance with ALCOA+ principles
• Conduct risk assessments and support Annual Product Quality Reviews (APQR)
• Perform line clearances and provide QA oversight during manufacturing activities
• Ensure compliance with GMP, USFDA, CDSCO, and global regulatory standards
• Support internal and external audits and address audit observations
• Monitor quality metrics and drive continuous improvement initiatives
• Coordinate with cross-functional departments to maintain quality standards
• Ensure timely closure of deviations and quality events

Required Qualifications
• 7–10 years of relevant experience in Quality Assurance within pharma or biopharma
• Strong knowledge of GMP and global regulatory guidelines
• Experience handling deviations, CAPA, OOS, OOT investigations
• Proficiency in document management systems and data integrity practices
• Ability to manage multiple priorities in a fast-paced environment
• Strong leadership and cross-functional coordination skills

Educational Requirements
• B.Pharm, M.Pharm, MSc (Biotechnology/Chemistry), or equivalent qualification
• Additional certifications in GMP or Regulatory Affairs are advantageous

Experience and Skills
• Strong understanding of ALCOA+ data integrity principles
• Experience conducting root cause investigations and risk assessments
• Excellent analytical and problem-solving skills
• Strong documentation review and approval experience
• Effective verbal and written communication skills
• Ability to mentor team members and drive accountability
• Experience supporting regulatory audits (USFDA, CDSCO, etc.)

Salary Insights
• Expected salary range: ₹8–15 LPA depending on experience and negotiation
• Performance-based incentives
• Health insurance coverage
• Provident Fund benefits
• Leave encashment policies
• Professional development and training opportunities

Company Overview
Provis Biolabs is an emerging biopharmaceutical organization committed to quality-driven manufacturing and regulatory excellence. With a focus on strengthening its Quality Assurance systems, the company provides opportunities for experienced professionals to contribute to high-standard pharmaceutical operations while growing within a dynamic and expanding environment.

Located in Jadcherla, Hyderabad, the facility supports regulated manufacturing practices aligned with global quality standards.

FAQs

Q: Is biologics experience mandatory?
A: Not mandatory, but experience in biopharmaceutical or regulated manufacturing environments is highly preferred.

Q: Will the role involve audit handling?
A: Yes, candidates are expected to support regulatory audits and manage compliance-related observations.

Q: Is this a team-handling role?
A: Yes, the position requires leadership skills and cross-functional coordination.

Q: What investigation tools are commonly used?
A: Root cause analysis tools such as Fishbone, 5-Why, and risk assessment methodologies are commonly applied.

Application Tips
• Clearly mention deviation and CAPA handling experience in your CV
• Highlight regulatory audit exposure (USFDA, CDSCO, etc.)
• Quantify improvements or compliance initiatives you led
• Mention experience with ALCOA+ and document management systems
• Demonstrate leadership and cross-functional collaboration experience
• Keep your CV structured and compliance-focused