We have an urgent requirement for the post of QC Manager with a fast growing Pharma Co. for their Plant manufacturing solid oral dosage forms & parenterals at Murbad (Kalyan Dist.). Please find the details below:
Company Name: Fast Growing Pharma Co.
Requirement: 1 Nos.
Job Location: Murbad (Kalyan Dist.), Maharashtra
Designation: QC Manager/ QC Head
Reporting Structure: CEO
Education: MSc.Chem or Microbiology, M. Pharma
Experience: 8-10 yrs in Pharma Mfg Co. Handling QC related functions (solid oral and parenterals)
Industry: Pharma/ Biotech
Function Area: Quality Control/ Quality Assurance
Key Skills: quality control, QC, parenterals, lyophilized injectables, calibration and validation of equipments, QC head, pharma, murbad
Salary Range: Rs. 8 to 10 lacs per annum
The QC Manager is referring to the Head of Quality and is responsible for:
· Oversee department operations, assuring that department is properly staffed, trained and supplied.
· Ensuring that the required initial and continuing training of his department personnel is carried out and adapted according to need.
· The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality;
· Ensuring that all necessary testing is carried out and the associated records evaluated;
· Approve specifications, sampling instructions, test methods and other Quality Control procedures;
· Ensuring the qualification and maintenance of his department, premises and equipment;
· Ensuring that the appropriate validations are done;
· Responsible for SOPs, change controls, deviations and CAPAs related to QC.
· Ensure and monitor adherence to all company policies and procedures relating to cGMP and GDP, SOPs and Health, Safety and Environmental Protection.
· Serve as key technical advisor/resource for the site, and ensure QC staff is appropriately trained to support plant operations, ensuring risks are identified and resolved.
· Participate in internal and regulatory agency audits.
· Conduct briefings and technical meetings for top management and representatives of process performance, product quality and of the quality management system and advocating continual improvement.
· Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
· M.S. in Pharmaceutical Sciences, Analytical Chemistry, Chemistry, microbiology or equivalent
· 8+ years of QC management experience in a pharmaceutical company, preferentially with parenterals and in global generic pharmaceutical companies.
· Experience in developing SOPs, protocols and technical documents.
· Experience in chemical and microbiological analysis of raw materials as well as finished products.
· Experienced in auditing and authority inspections
· Experience with validation and qualification of process equipment incl. lyophilizers, HVAC, PW and WFI generation, storage and distribution system.
· Experience with electronic systems such as LIMS, SAP and TrackWise is a plus.
· Ability to effectively communicate technical information in a clear, concise English language (written and verbal) within a GMP/GDP-regulated environment
If the position interests you, kindly write to us along with your CV at aspsol.recruitments[at]gmail.com, also mention your current/expected CTC, notice period