Bioplus is a leading pharmaceutical company committed to delivering high-quality products. We are seeking a highly experienced and motivated individual to lead our Quality Assurance (QA) team.
Job Summary
We are seeking a seasoned General Manager – Quality Assurance (Formulation) to join our team. This pivotal role will be responsible for leading and managing all aspects of the QA function for our OSD (Oral Solid Dosage) formulation operations. The successful candidate will ensure the highest standards of quality, compliance, and continuous improvement.
- Reports to: AVP – Technical Operations
- Location: Whitefield, Bangalore
- Employment Type: Full-time, Work From Office
- Apply to: talent@bioplus.in
Responsibilities
The General Manager – Quality Assurance (Formulation) will be responsible for the following:
Audit Management:
- Develop and implement a robust audit management system.
- Ensure compliance with regulatory requirements (FDA, cGMP, etc.).
Compliance and Regulatory Affairs:
- Stay current with regulatory guidelines and industry best practices.
- Act as a subject matter expert on quality and compliance.
- Represent the company during regulatory inspections and audits.
Team Leadership and Development:
- Provide strong leadership and guidance to the QA team.
- Foster a high-performance culture.
- Conduct performance evaluations and support career development.
- Manage and supervise the QA team, including hiring, training, and performance management.
Risk Assessment and Mitigation:
- Identify and mitigate potential risks in quality systems.
- Ensure effective root cause analysis and CAPA implementation.
Quality Systems and Procedures:
- Develop and implement quality policies, procedures, and systems.
- Develop and maintain a risk-based quality management system covering all aspects of the manufacturing process.
- Lead and coordinate all quality audits (internal and external).
Cross-Functional Collaboration & Process Improvement:
- Collaborate with cross-functional teams.
- Identify and implement process improvements.
Issue Resolution:
- Ensure timely resolution of quality issues and deviations through CAPAs.
Vendor Management:
- Conduct vendor audits and qualifications.
Licensing & Certifications:
- Handle local licensing and certifications.
Key Competencies:
- Handling major audits like EU, TGA, MHRA, and USFDA in the last 2 years.
Qualifications
- Education: Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field. An advanced degree is preferred.
- Experience: Minimum 20 years of experience in Quality Assurance within the Pharmaceutical Industry.
Skills
- Strong leadership and team management abilities.
- In-depth knowledge of pharmaceutical regulations (FDA, cGMP, etc.).
- Excellent communication and interpersonal skills.
- Problem-solving and analytical abilities.
- Experience with audit management and regulatory inspections.
- Risk assessment and mitigation expertise.
- Decision-making and recruitment skills.
- Talent resourcing and training skills.
Benefits
- Competitive salary and benefits package.
- Opportunity to lead and develop a high-performing QA team.
- Impactful role in ensuring product quality and regulatory compliance.
- Work in a dynamic and growing pharmaceutical company.
How to Apply
Interested candidates are requested to apply by sending their resume to talent@bioplus.in.