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Micro Labs Seeks Senior Quality Assurance Professional for Bangalore API R&D Center
Leading pharmaceutical manufacturer Micro Labs Limited is expanding its Development Quality Assurance team with an opening for an Assistant Manager/Deputy Manager position at their API R&D facility in Bommasandra, Bangalore.
About the Opportunity
As Micro Labs celebrates 50 years of excellence in pharmaceutical manufacturing, the company is strengthening its quality assurance capabilities at its Development Quality Assurance and API R&D Centre in Bangalore. This senior-level position offers an exciting opportunity for experienced quality professionals to contribute to the development and manufacturing of Active Pharmaceutical Ingredients (APIs)—the core components of pharmaceutical drugs.
Position Details
The role requires a seasoned professional with 7-8 years of experience in pharmaceutical quality assurance, holding either an M.Sc. in Chemistry or an M.Pharma qualification. The successful candidate will be based at the company’s Bommasandra facility, working within the critical API Research and Development division.
Key Responsibilities
The Assistant Manager/Deputy Manager will play a crucial role in maintaining and elevating quality standards across the development process. Primary responsibilities include:
· Technical Documentation and Validation: The role involves the comprehensive review of analytical method validation protocols and other critical analytical technical documents, ensuring compliance with industry standards and regulatory requirements.
· Standard Operating Procedures (SOPs): The position holder will be responsible for reviewing and implementing SOPs, a fundamental aspect of maintaining robust quality systems in pharmaceutical manufacturing.
· Internal Auditing: Conducting internal audits forms a key component of this role, requiring strong attention to detail and a deep understanding of quality management systems to identify and address potential gaps.
· Regulatory Compliance: The ideal candidate must demonstrate awareness and working knowledge of ICH (International Council for Harmonisation) guidelines and other relevant regulatory frameworks governing pharmaceutical development and manufacturing.
· Quality Management Systems: Managing QAMS (Quality Assurance Management System) documents is an essential function, requiring excellent organizational skills and a systematic approach to documentation control.
Ideal Candidate Profile
Micro Labs is seeking a quality assurance professional who combines technical expertise with practical experience in pharmaceutical development environments. The role demands someone who can balance regulatory compliance with operational efficiency, possess strong analytical skills, and demonstrate meticulous attention to detail in documentation and audit processes.
Candidates should have hands-on experience with analytical method validation, be well-versed in regulatory guidelines, and possess the ability to implement quality systems effectively. Strong communication skills are essential, as the role involves interaction with various departments and stakeholders.
Application Process
Interested candidates meeting the qualification and experience criteria can submit their applications to dibyasinghamahanty@microlabs.in.
Given the specialized nature of this position, candidates should ensure their applications clearly demonstrate relevant experience in pharmaceutical quality assurance, particularly in API development environments.
About Micro Labs Limited
With five decades of pharmaceutical manufacturing expertise, Micro Labs Limited has established itself as a significant player in the Indian pharmaceutical industry. The company’s focus on quality and innovation is reflected in its investment in dedicated R&D facilities and commitment to maintaining international quality standards.
FAQ:
1. What types of analytical method validations are typically reviewed in this role?
Answer:
The role involves reviewing analytical method validation protocols for assays, related substances, residual solvents, and impurities in Active Pharmaceutical Ingredients (APIs). The review ensures that validation parameters such as accuracy, precision, linearity, range, specificity, robustness, and detection/quantitation limits comply with ICH Q2(R2) guidelines and internal quality standards.
2. What are the key regulatory guidelines a Quality Assurance professional must be familiar with in API R&D?
Answer:
The candidate should have a solid understanding of ICH guidelines (such as ICH Q7 for GMP in APIs, ICH Q9 for Quality Risk Management, and ICH Q10 for Pharmaceutical Quality Systems), along with awareness of USFDA, EMA, and WHO GMP standards. Familiarity with ISO 9001 and regulatory inspection readiness practices is also beneficial.
3. How is Quality Assurance involved in the analytical data review process?
Answer:
QA professionals ensure that analytical data is complete, traceable, and compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available). This includes verifying raw data, chromatograms, and reports for consistency with approved methods, reviewing audit trails, and ensuring adherence to data integrity requirements.
4. What is the scope of internal auditing in the API R&D Quality Assurance function?
Answer:
Internal audits cover compliance with GMP, documentation practices, SOP adherence, laboratory controls, and method validation processes. QA identifies deviations, potential risks, and system weaknesses, then collaborates with functional teams to develop and monitor Corrective and Preventive Actions (CAPA).
5. How does QA manage Quality Assurance Management System (QAMS) documentation in R&D?
Answer:
QA oversees document control within QAMS, ensuring all quality-related documents (SOPs, validation protocols, deviation reports, change controls, and OOS/OOT investigations) are reviewed, approved, version-controlled, and archived. The role also involves maintaining document traceability, tracking review cycles, and supporting audits by providing accurate and retrievable documentation
