Opening for Head-QA (Injectables) @ Biocon

Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
Biocon together with group companies employs more than 2500 employees with approxmimately Rs 1,000 crore turnover and is expected to grow further during the current financial year.

Post: Head-QA (Injectables) - HC/JC/3063/2013

Job Description:
1.Technical expertise must includes aseptic manufacturing, sterilization processes, environmental monitoring, microbiological testing, laboratory and process development, validation of equipment, instrumentation and software, cGMP auditing, metrology systems and particulate matter characterization.
2.In partnership with cross-functional teams, lead the development and enhancement of key quality assurance programs supporting sterile manufacturing.
3.Accountable for product quality management including product test and disposition, change management, investigation/CAPA management and performance trend reporting at the aseptic manufacturing sites.
4.Responsible for quality activities that include: product assessment and final batch release, product quality performance management, annual product/quality reviews and compliance to Quality Management Systems.
5.Provide expert support to sites during regulatory inspection, development of responses to inspection findings, significant investigations and guidance regarding corrective actions.
6.Ensure that compliance issues identified by agency inspections are assessed for impact and effectively resolved.
7.Collaborate with key stakeholders within the organization to ensure successful execution of cGMP compliance throughout the aseptic contract manufacturing sites.
8.Provides quality talent management through performance management and training, in order to meet strategic and operational objectives.
9.Works closely with corporate Research and Development and Commercial teams during new product start-ups, and establishes key checkpoints for new aseptic products and processes.
10.Interfaces with regulatory agencies as required.

Skills:
1.Must have strong knowledge of cGMP (FDA, EU and ICH) requirements, FDA/EU regulatory guidelines, validation practices, Quality and Compliance principles for parenteral products.
2.Experience in Biopharmaceutical drug product manufacturing sites will be an advantage.
3.Established track record of Quality and Compliance decision-making
4.Established track record of successful regulatory inspections
5.Demonstrated leadership and execution of Quality Operations and processes for a sterile manufacturing environment.
6.Experience in managing multi site aseptic operations.
7.Extensive experience in technical Sterile Drug Product platforms (parenterals, inhalation drug products)
8.Working knowledge of risk management tools.
9.Demonstrated leadership ability to perform in a fast paced environment and create an exceptional working environment that motivates high performance.

Additional Information:
Experience: 15-20 Years
Location: Bangalore
Education: M.Pharm, M.Sc Microbiology
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 17^th Nov., 2013