Quality Assurance Manager/ Sr Manager
Location: Unit 2, Plot No. 209/A, Phase-III, Pashamylaram (V), Panchayat TSIIC-IALA, Patancheru (M), Sangareddy District, Telangana – 502307.
Preferred:
– 15+ years in pharmaceutical QA.
– Minimum 5-7 years in managerial or supervisory roles.
– Experience in formulations or semi formulations (Pellets) manufacturing, depending on the facility.
– Prior experience with regulatory audits (FDA, EMA, MHRA, etc.).
Technical Skills:
– Deep knowledge of GMP regulations, ICH guidelines, QMS, validation, and data integrity.
– Good experience with QMS systems and risk management tools.
– Leadership and team management.
– Strong communication and documentation skills.
– Analytical, problem-solving, and decision-making abilities, especially under regulatory oversight.
Key Responsibilities:
Below is a non-exhaustive list of responsibilities expected of the candidate.
- Quality System Management
– Develop, implement, and maintain the Quality Management System (QMS).
– Ensure compliance with cGMP, GLP, and other relevant regulations.
– Manage SOP creation, review, approval, and implementation.
- Regulatory Compliance
– Ensure adherence to Good Manufacturing Practices (GMP), other regulatory guidelines as well as Disto’s quality systems.
– Lead and coordinate regulatory inspections and internal audits.
– Address audit observations via CAPA processes.
- Batch Release & Documentation
– Review and approve manufacturing batch records.
– Authorise product release or rejection.
– Maintain accurate documentation, control, and data integrity.
- Deviation, CAPA & Risk Management
– Manage deviations, investigations, and root cause analysis.
– Oversee CAPA implementation and evaluation.
– Conduct risk assessments such as FMEA.
- Supplier & Vendor Quality
– Qualify and audit suppliers.
– Ensure raw materials meet quality standards.
– Oversee technical agreements.
- Validation & Change Control
– Supervise validation activities (e.g., process, cleaning, equipment qualification).
– Approve change controls and assess their impact on product quality.