Astral SteriTech Pvt. Ltd (formaly known as Astral Pharmaceutical Industries), symbolises dedication to quality, sincerity towards work and passion to achieve 100% customer satisfaction. ASTRAL SteriTech has carved its Niche as the specialized contract manufacturing company in the area of its core competence - Sterile Antibiotic Powder Injectable formulations. ASTRAL SteriTech is poised to explore the opportunities offered by the Global market for sterile antibiotic powder injectable formulations on the strength of its unique manufacturing facilities, Quality systems and trained human resource.
Post : Assistant Quality Assurance Manager
Job description
- Serve as the central point of linkage across the organization to oversee monitoring of quality issues identified and lead the development and execution of strategies for providing QMS (Quality Management Systems ) monitoring.
- Lead independent monitoring across QMS process (includes monitoring CAPAs, quality events, systems and data) to ensure attainment of short-term goals (e.g. inspection readiness) and meet long-term objectives (sustainable assurance and oversight of CAPA implementation).
- Ensure the effective functioning of CAPA system/process to eliminate the causes of detected discrepancies (reactive), preventive actions are in place to eliminate the causes of potential discrepancies of other undesirable situations (proactive).
- Develop and facilitate mechanisms/processes to identify potential gaps or opportunities for improvement and recommendations to improve the QMS (i.e. effectiveness of CAPAs, proactive identification of quality issues, appropriate metrics for QMS health etc.), management of quality events. Generate regular and ad hoc status reports on the state of the QMS control, system health and provides meaningful interpretation of trends and signals identified.
- Initiate notification and/or escalation of emerging and signification risks to the relevant senior management
- Maintain appropriate level of expertise in US and international GCP/GLP/PV regulatory requirements, policies, SOPs..
Desired Skills and Experience
Corrective and Preventive Action (CAPA) Cleaning Validation Good Laboratory Practice (GLP) Change Control Quality Assurance GMP Validation
Additional Information:
Location : Vadodara, Gujarat
Industry Type : Pharma / Biotech / Clinical Research
Functional Area : QA
Last date : 25th september, 2016
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